Device, system, and method for transcatheter treatment of valvular regurgitation

ABSTRACT

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/153,480, filed May 12, 2016, which in turn claims priorityunder 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/252,336,filed on Nov. 6, 2015. Each of the foregoing applications of which arehereby incorporated by reference in their entireties. Any and allapplications for which a foreign or domestic priority claim isidentified in the Application Data Sheet as filed with the presentapplication, are hereby incorporated by reference in their entiretyunder 37 CFR 1.57.

BACKGROUND

Field

The present disclosure generally provides improved medical devices,systems, and methods, typically for treatment of heart valve diseaseand/or for altering characteristics of one or more valves of the body.Embodiments include implants for treatment of mitral valveregurgitation.

The human heart receives blood from the organs and tissues via theveins, pumps that blood through the lungs where the blood becomesenriched with oxygen, and propels the oxygenated blood out of the heartto the arteries so that the organ systems of the body can extract theoxygen for proper function. Deoxygenated blood flows back to the heartwhere it is once again pumped to the lungs.

The heart includes four chambers: the right atrium (RA), the rightventricle (RV), the left atrium (LA) and the left ventricle (LV). Thepumping action of the left and right sides of the heart occurs generallyin synchrony during the overall cardiac cycle.

The heart has four valves generally configured to selectively transmitblood flow in the correct direction during the cardiac cycle. The valvesthat separate the atria from the ventricles are referred to as theatrioventricular (or AV) valves. The AV valve between the left atriumand the left ventricle is the mitral valve. The AV valve between theright atrium and the right ventricle is the tricuspid valve. Thepulmonary valve directs blood flow to the pulmonary artery and thence tothe lungs; blood returns to the left atrium via the pulmonary veins. Theaortic valve directs flow through the aorta and thence to the periphery.There are normally no direct connections between the ventricles orbetween the atria.

The mechanical heartbeat is triggered by an electrical impulse, whichspreads throughout the cardiac tissue. Opening and closing of heartvalves may occur primarily as a result of pressure differences betweenchambers, those pressures resulting from either passive filling orchamber contraction. For example, the opening and closing of the mitralvalve may occur as a result of the pressure differences between the leftatrium and the left ventricle.

At the beginning of ventricular filling (diastole) the aortic andpulmonary valves are closed to prevent back flow from the arteries intothe ventricles. Shortly thereafter, the AV valves open to allowunimpeded flow from the atria into the corresponding ventricles. Shortlyafter ventricular systole (i.e., ventricular emptying) begins, thetricuspid and mitral valves normally shut, forming a seal, whichprevents flow from the ventricles back into the corresponding atria.

Unfortunately, the AV valves may become damaged or may otherwise fail tofunction properly, resulting in improper closing. The AV valves arecomplex structures that generally include an annulus, leaflets, chordaeand a support structure. Each atrium interfaces with its valve via anatrial vestibule. The mitral valve has two leaflets; the analogousstructure of the tricuspid valve has three leaflets, and apposition orengagement of corresponding surfaces of leaflets against each otherhelps provide closure or sealing of the valve to prevent blood flowingin the wrong direction. Failure of the leaflets to seal duringventricular systole is known as malcoaptation, and may allow blood toflow backward through the valve (regurgitation). Heart valveregurgitation can have serious consequences to a patient, oftenresulting in cardiac failure, decreased blood flow, lower bloodpressure, and/or a diminished flow of oxygen to the tissues of the body.Mitral regurgitation can also cause blood to flow back from the leftatrium to the pulmonary veins, causing congestion. Severe valvularregurgitation, if untreated, can result in permanent disability ordeath.

Description of the Related Art

A variety of therapies have been applied for treatment of mitral valveregurgitation, and still other therapies may have been proposed but notyet actually used to treat patients. While several of the knowntherapies have been found to provide benefits for at least somepatients, still further options would be desirable. For example,pharmacologic agents (such as diuretics and vasodilators) can be usedwith patients having mild mitral valve regurgitation to help reduce theamount of blood flowing back into the left atrium. However, medicationscan suffer from lack of patient compliance. A significant number ofpatients may occasionally (or even regularly) fail to take medications,despite the potential seriousness of chronic and/or progressivelydeteriorating mitral valve regurgitation. Pharmacological therapies ofmitral valve regurgitation may also be inconvenient, are oftenineffective (especially as the condition worsens), and can be associatedwith significant side effects (such as low blood pressure).

A variety of surgical options have also been proposed and/or employedfor treatment of mitral valve regurgitation. For example, open-heartsurgery can replace or repair a dysfunctional mitral valve. Inannuloplasty ring repair, the posterior mitral annulus can be reduced insize along its circumference, optionally using sutures passed through amechanical surgical annuloplasty sewing ring to provide coaptation. Opensurgery might also seek to reshape the leaflets and/or otherwise modifythe support structure. Regardless, open mitral valve surgery isgenerally a very invasive treatment carried out with the patient undergeneral anesthesia while on a heart-lung machine and with the chest cutopen. Complications can be common, and in light of the morbidity (andpotentially mortality) of open-heart surgery, the timing becomes achallenge—sicker patients may be in greater need of the surgery, butless able to withstand the surgery. Successful open mitral valvesurgical outcomes can also be quite dependent on surgical skill andexperience.

Given the morbidity and mortality of open-heart surgery, innovators havesought less invasive surgical therapies. Procedures that are done withrobots or through endoscopes are often still quite invasive, and canalso be time consuming, expensive, and in at least some cases, quitedependent on the operator's skill. Imposing even less trauma on thesesometimes frail patients would be desirable, as would be providingtherapies that could be successfully implemented by a significant numberof physicians using widely distributed skills. Toward that end, a numberof purportedly less invasive technologies and approaches have beenproposed. These include devices which seek to re-shape the mitralannulus from within the coronary sinus; devices that attempt to reshapethe annulus by cinching either above to below the native annulus;devices to fuse the leaflets (imitating the Alfieri stitch); devices tore-shape the left ventricle, and the like.

Perhaps most widely known, a variety of mitral valve replacementimplants have been developed, with these implants generally replacing(or displacing) the native leaflets and relying on surgically implantedstructures to control the blood flow paths between the chambers of theheart. While these various approaches and tools have met with differinglevels of acceptance, none has yet gained widespread recognition as anideal therapy for most or all patients suffering from mitral valveregurgitation.

Because of the challenges and disadvantages of known minimally invasivemitral valve regurgitation therapies and implants, still furtheralternative treatments have been proposed. Some of the alternativeproposals have called for an implanted structure to remain within thevalve annulus throughout the heart beat cycle. One group of theseproposals includes a cylindrical balloon or the like to remain implantedon a tether or rigid rod extending between the atrium and the ventriclethrough the valve opening. Another group relies on an arcuate ringstructure or the like, often in combination with a buttress orstructural cross-member extending across the valve so as to anchor theimplant. Unfortunately, sealing between the native leaflets and the fullperimeter of a balloon or other coaxial body may prove challenging,while the significant contraction around the native valve annulus duringeach heart beat may result in significant fatigue failure issues duringlong-term implantation if a buttress or anchor interconnecting crossmember is allowed to flex. Moreover, the significant movement of thetissues of the valve may make accurate positioning of the implantchallenging regardless of whether the implant is rigid or flexible.

In light of the above, it would be desirable to provide improved medicaldevices, systems, and methods. It would be particularly desirable toprovide new techniques for treatment of mitral valve regurgitation andother heart valve diseases, and/or for altering characteristics of oneor more of the other valves of the body. The need remains for a devicewhich can directly enhance leaflet coaptation (rather than indirectlyvia annular or ventricular re-shaping) and which does not disruptleaflet anatomy via fusion or otherwise, but which can be deployedsimply and reliably, and without excessive cost or surgical time. Itwould be particularly beneficial if these new techniques could beimplemented using a less-invasive approach, without stopping the heartor relying on a heart-lung machine for deployment, and without relyingon exceptional skills of the operator to provide improved valve and/orheart function.

SUMMARY

The disclosure generally provides improved medical devices, systems, andmethods. New coaptation assistance elements, systems, and methods fortreatment of mitral valve regurgitation and other valve diseases aredisclosed. The coaptation assistance element may remain within the bloodflow path as the valve moves back and forth between an open-valveconfiguration and a closed valve configuration. The coaptationassistance elements may be relatively thin, elongate (along the bloodflow path), and/or conformable structures which extend laterally acrosssome, most, or all of the width of the valve opening, allowingcoaptation between at least one of the native leaflets and thecoaptation assistance element. The devices described herein can be usedwith any valve of the human body, including valves with two leaflets orthree leaflets.

In some embodiments, an advantage is the ability to retrieve thecoaptation assistance element. In some embodiments, the coaptationassistance element has a single anchor, which can engage or disengagetissue. In some embodiments, the anchor is captive within an annular hubof the coaptation assistance element. In some embodiments, the captiveanchor is removed simultaneously with the removal of the coaptationassistance element. In some embodiments, the coaptation assistanceelement can include secondary anchors. In some embodiments, thecoaptation assistance element can include passive anchors. In someembodiments, engagement of the anchor with the tissue positions one ormore passive anchors into engagement with tissue. In some embodiments,an advantage is to retrieve the coaptation assistance element during aprocedure. In some embodiments, the coaptation assistance element can berepositioned during a surgical procedure. In some embodiments, thecoaptation assistance element can be removed from the patient during asubsequent surgical procedure. In some embodiments, the coaptationassistance element can be replaced by another device during a subsequentsurgical procedure. In some embodiments, a single annular anchorfacilitates the ability to retrieve the coaptation assistance element.In some embodiments, the location of the annular anchor facilitates theability to retrieve the coaptation assistance element. In someembodiments, the ability to collapse the coaptation assistance elementwith the purse-string suture as described herein facilitates the abilityto retrieve the coaptation assistance element.

In some embodiments, an advantage is the connection between thecoaptation assistance element and the delivery catheter. In someembodiments, the coaptation assistance element includes an annular hubwith features to engage the delivery catheter. In some embodiments, thecoaptation assistance element and the delivery catheter are removablycoupled such that the coaptation assistance element can be released fromthe delivery catheter during a procedure. In some embodiments, one ormore secondary structures couples the coaptation assistance element andthe delivery catheter after the coaptation assistance element isreleased from the delivery catheter. In some embodiments, the one ormore secondary structures include the purse-string suture as descriedherein. In some embodiments, the one or more secondary structuresfacilitate the collapse and/or expansion of the coaptation assistanceelement. In some embodiments, the coaptation assistance element and thedelivery catheter are rotationally fixed relative to each other whencoupled. In some embodiments, relative motion of the delivery cathetercauses motion of the coaptation assistance element.

In some embodiments, an advantage is the coaptation assistance elementcan be delivered with a hub-leading orientation. In some methods of use,the annular hub can be moved into position relative to the anatomicalstructures. In some methods of use, the ventricular end of thecoaptation assistance element can be retained within the deliverycatheter until the annular hub is positioned. In some methods of use,once the annular hub and/or the annular anchor are engaged with thetissue, the coaptation assistance element can be expanded. In somemethods of use, once the annular hub and/or the annular anchor areengaged with the tissue, the ventricular end of the coaptationassistance element can be positioned.

In some embodiments, an advantage is the coaptation assistance elementcan be delivered with a strut-leading orientation. In this method ofuse, one or more of the struts of the coaptation assistance element canbe moved into position relative to the anatomical structures prior tothe positioning of the annular hub. In some methods of use, thecoaptation assistance element can be expanded or partially expandedprior to the engagement of the annular anchor. In some methods of use,the annular hub can be retained within the delivery catheter until oneor more of the struts are positioned. In some methods of use, once thestruts are positioned, the annular anchor can be engaged with thetissue.

In some embodiments, an advantage is the annular anchor can be rotatedindependently of the coaptation assistance element. As described herein,the coaptation assistance element is coupled to one portion of thedelivery catheter. As described herein, the annular anchor isindependently coupled to another portion of the delivery catheter, suchas a driver disposed with the delivery catheter. The annular anchor canbe rotated independently of the annular hub. The annular hub can remainstationary as the annular anchor is rotated to engage tissue. Theannular anchor can be driven into the tissue while the delivery catheterretains the position of the annular hub.

In some embodiments, an advantage is the ability to collapse thecoaptation assistance element. In some embodiments, the coaptationassistance element is fully collapsed. The fully collapsed configurationcan be the insertion configuration or a low profile configuration. Insome embodiments, the coaptation assistance element is partiallycollapsed. The partially collapsed configuration can be a partiallydeployed configuration. The partially collapsed configuration can allowthe coaptation assistance element to be selectively deployed within theheart. The partially collapsed configuration can allow the coaptationassistance element to be moved into position within the heart. Theconfigurations of the coaptation assistance element can be monitoredsuch as by imaging to ensure proper deployment. In some embodiments, oneor more purse-string sutures, or portions thereof, are tensioned tocollapse or partially collapse the coaptation assistance element. Insome embodiments, the partially collapsed configuration can allowrotation of the coaptation assistance element. In some embodiments, thefully collapsed configuration can allow rotation of the coaptationassistance element. In some embodiments, the coaptation assistanceelement can be rotated with a delivery catheter or portion thereof. Insome embodiments, the coaptation assistance element can be rotated abouta central location such as the annular hub.

In some embodiments, an advantage is the ability to expand thecoaptation assistance element. In some embodiments, one or morepurse-string sutures, or portions thereof, are released to expand thecoaptation assistance element. In some embodiments, release of thepurse-string suture allows one or more struts to assume a neutralconfiguration. In some embodiments, the release of the purse-stringsuture allows one or more struts to assume a pre-shaped curve. In someembodiments, the one or more struts comprise NiTi. In some embodiments,the purse-string suture can be repeatedly tensioned and/or released. Insome embodiments, the purse-string suture is captive within thecoaptation assistance element. In some embodiments, the purse-stringsuture is tensioned to remove the coaptation assistance element from apatient. In some embodiments, the purse-string suture is released todeploy the coaptation assistance element within the heart of a patient.In some embodiments, the purse-string suture can be selective deployedto expand a portion of coaptation assistance element while anotherportion of the coaptation assistance element remains collapsed orpartially collapsed.

In some embodiments, an advantage is the ability to adjust thecoaptation assistance element. In some embodiments, the coaptationassistance element can be held by a central location. In someembodiments, the central location is the anchor. In some embodiments,the central location is the hub. In some embodiments, the hub and/or theanchor are located generally near a mid-point of the diameter of thecoaptation assistance element. In some embodiments, the hub and/or theanchor are generally located near a mid-point and/or central location ofthe annular portion of the coaptation assistance element. In someembodiments, the coaptation assistance element can be held at a neutralposition. In some embodiments, the coaptation assistance element can berotated by rotating a delivery catheter connected to the annular hub. Insome embodiments, the coaptation assistance element can be movedlongitudinally by corresponding longitudinal motion of a deliverycatheter connected to the annular hub.

In some embodiments, an advantage is the coaptation assistance elementcan be retained by a delivery catheter after the coaptation assistanceelement is positioned. In some embodiments, the coaptation assistanceelement can be fully deployed within the mitral valve but still tetheredto a delivery catheter. In some embodiments, the coaptation assistanceelement can be adjusted after the coaptation assistance element is fullydeployed within the mitral valve. In some embodiments, the coaptationassistance element can be rotated about the hub after the coaptationassistance element is fully deployed. In some embodiments, the anchorcan be disengaged and/or reengaged with the tissue after the coaptationassistance element is fully deployed. In some embodiments, thepurse-string sutures can collapse and/or expand the coaptationassistance element or a portion thereof after the coaptation assistanceelement is fully deployed. In some embodiments, the coaptationassistance element can be recaptured after the coaptation assistanceelement is fully deployed. In some embodiments, the coaptationassistance element can be removed after the coaptation assistanceelement is fully deployed.

In some embodiments, an advantage is the coaptation assistance elementdoes not require ventricular attachment. In some embodiments, thecoaptation assistance element only requires annular attachment. In someembodiments, the coaptation assistance element only requires attachmentof an annular anchor through an annular hub. In some embodiments, thecoaptation assistance element only requires attachment of an annularanchor through an annular hub and annular barbs. In some embodiments,the coaptation assistance element only requires attachment of an annularanchor through an annular hub, annular barbs, and/or commissural barbs.

In some embodiments, an advantage is the radially extending frame. Insome embodiments, the frame comprises an annular hub and one or morestruts. In some embodiments, the struts extend radially from the annularhub. In some embodiments, the frame is constructed from a single, planarsheet of material. In some embodiments, the frame is precisely cut usingwater jet, laser etching or similar technology. In some embodiments, theframe is constructed by forming the annular hub with an edge of theframe. In some embodiments, the planar sheet of material is formed intoa loop which becomes the annular hub. In some embodiments, the strutsare bent to the desired configuration. In some embodiments, the strutsare equally spaced about the circumference of the annular hub. In someembodiments, the struts are unequally spaced about the circumference ofthe annular hub. In some embodiments, the struts extending along aportion of the circumference of the annular hub are different thanstruts extending along another portion of the circumference of theannular hub. In some embodiments, one or more designated portions of thestruts are designed to be placed near the annular region of the heart.In some embodiments, one or more designated portions of the struts aredesigned to be placed near the commissure region of the heart. In someembodiments, one or more designated portions of the struts are designedto be placed near the ventricular region of the heart. In someembodiments, the struts of the radially outward frame do not intersect.In some embodiments, the struts of the radially outward frame do notform a mesh. In some embodiments, the struts of the radially outwardframe extend in a line from the hub to an edge of the coaptationassistance element. In some embodiments, the struts of the radiallyoutward frame have a sharpened edge. In some embodiments, the sharpenededge extends in a straight line from the edge of the coaptationassistance element. In some embodiments, the sharpened edge isintegrally formed in the strut. In some embodiments, a strut of theradially outward frame has one or more radii of curvature. In someembodiments, a strut of the radially outward frame can be concave orconvex or both concave and convex along the length of the strut. In someembodiments, a strut of the radially outward frame has one or moreinflection points.

In some embodiments, an advantage is the curvature of the frame. In someembodiments, the annular hub is radially extending. In some embodiments,the annular hub extends from the coaptation assistance element away fromthe annulus. In some embodiments, the annular hub extends from a surfaceof the coaptation assistance element above a planar surface of thestruts. In some embodiments, an edge of the coaptation assistanceelement is curved. In some embodiments, one or more struts may curvelaterally from the annular hub toward the superior edge. In someembodiments, the superior edge of the coaptation assistance element cancurve upward from the annulus. In some embodiments, the superior edge ofthe coaptation assistance element can curve upward from the posteriorleaflet. In some embodiments, the superior edge of the coaptationassistance element can curve downward toward the annulus. In someembodiments, the superior edge of the coaptation assistance element cancurve downward toward the posterior leaflet. In some embodiments, one ormore struts may curve laterally from the annular hub toward the inferioredge. In some embodiments, the inferior edge of the coaptationassistance element can curve away from the posterior leaflet. In someembodiments, the inferior edge of the coaptation assistance element cancurve toward the posterior leaflet.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve in provided. The heart valve has anannulus. The coaptation assistance element can include a body thatincludes an annular section and a coaptation section. In someembodiments, the annular section is configured to be implanted within aheart superior to a valve annulus. In some embodiments, the coaptationzone configured to be implanted within a heart and traversing a plane ofthe valve annulus. The coaptation assistance element can include a firstcoaptation surface, and an opposed second surface. In some embodiments,each surface is bounded by a first lateral edge, a second lateral edge,an inferior edge, and a superior edge. In some embodiments, the superioredge forms a lip and cupped downward toward the inferior edge or upwardfrom the annular section. The coaptation assistance element can includea hub and an anchor coupled to the hub and carried by the annularsection. In some embodiments, the anchor is selectively deployable at afirst target location. The coaptation assistance element can include aplurality of struts extending radially outward from the hub. In someembodiments, the plurality of struts comprise at least a first strutresiding within the annular section and a second strut extending fromthe annular section to the coaptation section, wherein the second struthas a total length that is longer than that of the first strut, such as,for example, a total length that is about, or at least about 110%, 120%,130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 225%, 250% or more ofthe total length of the first strut. In some embodiments, the totallength of the second strut is between about 125% and about 300%, orbetween about 125% and 200% of the total length of the first strut.

In some embodiments, at least one strut of the plurality of struts has asharpened tip configured to engage tissue. In some embodiments, theplurality of struts comprises Nitinol. In some embodiments, the anchoris helical-shaped. The coaptation assistance element can include one ormore additional anchors. In some embodiments, the one or more additionalanchors are active anchors. In some embodiments, the hub comprises across-pin configured to extend through a helix of the anchor. In someembodiments, the hub is configured to mate with a delivery catheter,wherein the delivery catheter is configured to position the hub near thefirst target location. In some embodiments, the delivery catheter isconfigured to rotate the anchor independently of the hub. The coaptationassistance element can include a radiopaque marker. The coaptationassistance element can include a plurality of radiopaque markers nearthe superior edge. In some embodiments, the superior edge forming a lipis cupped downward toward the inferior edge. In some embodiments, thesuperior edge forming a lip is cupped upward from the annular section.In some embodiments, the hub extends upward from the annular section. Insome embodiments, the inferior edge curves backwards toward the hub.

In some embodiments, a method for treating mal-coaptation of a heartvalve in a patient is provided. The heart valve has an annulus. Theannulus further defines a valve plane, the valve plane separating anatrium proximally and a ventricle distally. The method can include thestep of coupling a delivery catheter to a hub of a coaptation assistanceelement. The method can include the step of positioning the hub near theannulus. The method can include the step of rotating an anchor throughthe hub and into heart tissue distal to the annulus. The method caninclude the step of expanding the coaptation assistance element byallowing a plurality of struts to expand radially outward from the hub.

In some embodiments, the coaptation assist body is suspended such thatthe coaptation surface coapts with a first leaflet and a leaflet surfaceof the coaptation assist body overlays a second leaflet such thatmal-coaptation is mitigated. The method can include the step of engaginga sharpened end of a strut of the plurality of struts with heart tissuedistal to the annulus. The method can include the step of monitoring theposition of the coaptation assistance element with one or more markers.The method can include the step of monitoring the position of thecoaptation assistance element with a plurality of markers near asuperior edge of the coaptation assistance element. In some embodiments,a tip of the anchor is recessed in the hub during positioning the hubnear the annulus.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A-1F schematically illustrate some of the tissues of the heart andmitral valve, as described in the Background section and below, andwhich may interact with the implants and systems described herein.

FIG. 2A illustrates a simplified cross-section of a heart, schematicallyshowing mitral valve function during diastole.

FIG. 2B illustrates a simplified cross-section of a heart, schematicallyshowing mitral valve function during systole.

FIGS. 3A-3B illustrate a simplified cross-section of a heart,schematically showing mitral valve regurgitation during systole in thesetting of mal-coaptation of the mitral valve leaflets.

FIG. 4A illustrates a stylized cross section of a heart, showing mitralvalve mal-coaptation in the setting of functional mitral valveregurgitation.

FIG. 4B illustrates a stylized cross section of a heart, showing mitralvalve mal-coaptation in the setting of degenerative mitral valveregurgitation.

FIG. 5A illustrates a perspective view of an embodiment of a coaptationassistance element.

FIG. 5B illustrates the top view of the coaptation assistance element ofFIG. 5A.

FIG. 5C-5D illustrates an embodiment of the struts of a coaptationassistance element.

FIGS. 5E-5G illustrate the coaptation assistance element of FIG. 5Awithout annular anchor site.

FIGS. 5H-5J illustrate the coaptation assistance element of FIG. 5A withleaflet anchor sites.

FIG. 5K illustrates dimensions of the coaptation assistance element ofFIG. 5A.

FIG. 6 illustrates a perspective view of an embodiment of a coaptationassistance element.

FIG. 7A illustrates a perspective view of an embodiment of a coaptationassistance element showing a first surface disposed toward amal-coapting native leaflet.

FIG. 7B illustrates another perspective view of the coaptationassistance element of FIG. 7A showing a second surface which can includea coaptation surface.

FIG. 7C illustrates a top view of the coaptation assistance element ofFIG. 7A.

FIG. 7D illustrates the coaptation assistance element of FIG. 7Aimplanted within a model of a mitral valve.

FIG. 7E illustrates a top view of the coaptation assistance element ofFIG. 7A implanted within a model of a mitral valve.

FIG. 8A schematically illustrates an embodiment of control handle of adelivery system for a transcatheter technique.

FIG. 8B schematically illustrates a top view and a side view acoaptation assistance element coupled to the delivery system of FIG. 8A.

FIG. 8C schematically illustrates the connection between an annular hubof the coaptation assistance element and a tip of the delivery catheter.

FIG. 9A schematically illustrates the anchor manipulation of thedelivery system of FIG. 8A.

FIGS. 9B-9E schematically illustrates embodiments of the connectionbetween an annular anchor and a driver.

FIG. 10 schematically illustrates a method step for a transcathetertechnique showing transseptal crossing.

FIG. 11 schematically illustrates a method step for a transcathetertechnique showing initial coaptation assistance element advancement.

FIG. 12 schematically illustrates a method step for a transcathetertechnique showing partial coaptation assistance element opening.

FIG. 13 schematically illustrates a method step for a transcathetertechnique showing coaptation assistance element collapsing.

FIG. 14 schematically illustrates a method step for a transcathetertechnique showing a cross-sectional view of the coaptation assistanceelement.

FIG. 15 schematically illustrates a method step for a transcathetertechnique showing secondary anchor placement.

DETAILED DESCRIPTION

The present invention, in some embodiments, generally provides improvedmedical devices, systems, and methods, often for treatment of mitralvalve regurgitation and other valve diseases including tricuspidregurgitation. While the description that follows includes reference tothe anterior leaflet in a valve with two leaflets such as the mitralvalve, it is understood that “anterior leaflet” could refer to one ormore leaflets in valve with multiple leaflets. For example, thetricuspid valve has 3 leaflets so the “anterior” could refer to one ortwo of the medial, lateral, and posterior leaflets. The coaptationassistance elements described herein will generally include a coaptationassist body (sometimes referred to herein as a valve body) which isgenerally along the blood flow path as the leaflets of the valve moveback and forth between an open-valve configuration (with the anteriorleaflet separated from valve body) and a closed-valve configuration(with the anterior leaflet engaging opposed surfaces of the valve body).The valve body will be disposed between the native leaflets to close thegap caused by mal-coaptation of the native leaflets by providing asurface for at least one of the native leaflets to coapt against, whileeffectively replacing a second native leaflet in the area of the valvewhich, were it functioning normally, it would occlude during systole.The gaps may be lateral (such as may be caused by a dilated leftventricle and/or mitral valve annulus) and/or axial (such as where oneleaflet prolapses or is pushed by fluid pressure beyond the annulus whenthe valve should close). In some embodiments, the coaptation assistelements may completely assist one, two, or more valve leaflets, or insome embodiments partially assist a valve leaflet, for example, coveringonly one or more of the A1, A2, and/or A3 scallops of the anteriorleaflet, and/or one or more of the P1, P2, and/or P3 scallops of theposterior leaflet.

Among other uses, the coaptation assistance elements, and methodsdescribed herein may be configured for treating functional and/ordegenerative mitral valve regurgitation (MR) by creating an artificialor new coaptation zone within which at least one of the native mitralvalve leaflets can seal. The structures and methods herein will largelybe tailored to this application, though alternative embodiments might beconfigured for use in other valves of the heart and/or body, includingthe tricuspid valve, valves of the peripheral vasculature, the inferiorvena cava, or the like.

Referring to FIGS. 1A-1D, the four chambers of the heart are shown, theleft atrium 10, right atrium 20, left ventricle 30, and right ventricle40. The mitral valve 60 is disposed between the left atrium 10 and leftventricle 30. Also shown are the tricuspid valve 50 which separates theright atrium 20 and right ventricle 40, the aortic valve 80, and thepulmonary valve 70. The mitral valve 60 is composed of two leaflets, theanterior leaflet 12 and posterior leaflet 14. In a healthy heart, thetwo leaflets appose during systole at the coaptation zone 16.

The fibrous annulus 120, part of the cardiac skeleton, providesattachment for the two leaflets of the mitral valve, referred to as theanterior leaflet 12 and the posterior leaflet 14. The leaflets areaxially supported by attachment to the chordae tendinae 32. The chordae,in turn, attach to one or both of the papillary muscles 34, 36 of theleft ventricle. In a healthy heart, the chordae support structurestether the mitral valve leaflets, allowing the leaflets to open easilyduring diastole but to resist the high pressure developed duringventricular systole. In addition to the tethering effect of the supportstructure, the shape and tissue consistency of the leaflets helpspromote an effective seal or coaptation. The leading edges of theanterior and posterior leaflet come together along a funnel-shaped zoneof coaptation 16, with a lateral cross-section 160 of thethree-dimensional coaptation zone (CZ) being shown schematically in FIG.1E.

The anterior and posterior mitral leaflets are dissimilarly shaped. Theanterior leaflet is more firmly attached to the annulus overlying thecentral fibrous body (cardiac skeleton), and is somewhat stiffer thanthe posterior leaflet, which is attached to the more mobile posteriormitral annulus. Approximately 80 percent of the closing area is theanterior leaflet. Adjacent to the commissures 110, 114, on or anteriorto the annulus 120, lie the left (lateral) 124 and right (septal) 126fibrous trigones which are formed where the mitral annulus is fused withthe base of the non-coronary cusp of the aorta (FIG. 1F). The fibroustrigones 124, 126 form the septal and lateral extents of the centralfibrous body 128. The fibrous trigones 124, 126 may have an advantage,in some embodiments, as providing a firm zone for stable engagement withone or more annular or atrial anchors. The coaptation zone CL betweenthe leaflets 12, 14 is not a simple line, but rather a curvedfunnel-shaped surface interface. The first 110 (lateral or left) andsecond 114 (septal or right) commissures are where the anterior leaflet12 meets the posterior leaflet 14 at the annulus 120. As seen mostclearly in the axial views from the atrium of FIGS. 1C, 1D, and 1F, anaxial cross-section of the coaptation zone generally shows the curvedline CL that is separated from a centroid of the annulus CA as well asfrom the opening through the valve during diastole CO. In addition, theleaflet edges are scalloped, more so for the posterior versus theanterior leaflet. Mal-coaptation can occur between one or more of theseA-P (anterior-posterior) segment pairs A1/P1, A2/P2, and A3/P3, so thatmal-coaptation characteristics may vary along the curve of thecoaptation zone CL.

Referring now to FIG. 2A, a properly functioning mitral valve 60 of aheart is open during diastole to allow blood to flow along a flow pathFP from the left atrium toward the left ventricle 30 and thereby fillthe left ventricle. As shown in FIG. 2B, the functioning mitral valve 60closes and effectively seals the left ventricle 30 from the left atrium10 during systole, first passively then actively by increase inventricular pressure, thereby allowing contraction of the heart tissuesurrounding the left ventricle to advance blood throughout thevasculature.

Referring to FIGS. 3A-3B and 4A-4B, there are several conditions ordisease states in which the leaflet edges of the mitral valve fail toappose sufficiently and thereby allow blood to regurgitate in systolefrom the ventricle into the atrium. Regardless of the specific etiologyof a particular patient, failure of the leaflets to seal duringventricular systole is known as mal-coaptation and gives rise to mitralregurgitation.

Generally, mal-coaptation can result from either excessive tethering bythe support structures of one or both leaflets, or from excessivestretching or tearing of the support structures. Other, less commoncauses include infection of the heart valve, congenital abnormalities,and trauma. Valve malfunction can result from the chordae tendineaebecoming stretched, known as mitral valve prolapse, and in some casestearing of the chordae 215 or papillary muscle, known as a flail leaflet220, as shown in FIG. 3A. Or if the leaflet tissue itself is redundant,the valves may prolapse so that the level of coaptation occurs higherinto the atrium, opening the valve higher in the atrium duringventricular systole 230. Either one of the leaflets can undergo prolapseor become flail. This condition is sometimes known as degenerativemitral valve regurgitation.

In excessive tethering, as shown in FIG. 3B, the leaflets of a normallystructured valve may not function properly because of enlargement of orshape change in the valve annulus: so-called annular dilation 240. Suchfunctional mitral regurgitation generally results from heart musclefailure and concomitant ventricular dilation. And the excessive volumeload resulting from functional mitral regurgitation can itselfexacerbate heart failure, ventricular and annular dilation, thusworsening mitral regurgitation.

FIG. 4A-4B illustrate the backflow BF of blood during systole infunctional mitral valve regurgitation (FIG. 4A) and degenerative mitralvalve regurgitation (FIG. 4B). The increased size of the annulus in FIG.4A, coupled with increased tethering due to hypertrophy of the ventricle320 and papillary muscle 330, prevents the anterior leaflet 312 andposterior leaflet 314 from apposing, thereby preventing coaptation. InFIG. 4B, the tearing of the chordae 215 causes prolapse of the posteriorleaflet 344 upward into the left atrium, which prevents appositionagainst the anterior leaflet 342. In either situation, the result isbackflow of blood into the atrium, which decreases the effectiveness ofleft ventricle compression.

Further description of coaptation assistance elements, tools, anchors,features, systems, and methods, which can be utilized in conjunctionwith the disclosure herein, can be found in the following applications,each of which is incorporated by reference in their entirety: U.S.patent application Ser. No. 13/099,532, filed May 3, 2011; U.S. patentapplication Ser. No. 13/531,407, filed Jun. 22, 2012; U.S. patentapplication Ser. No. 14/313,975, filed Jun. 24, 2014; U.S. patentapplication Ser. No. 14/742,199, filed Jun. 17, 2015; U.S. patentapplication Ser. No. 14/749,344, filed Jun. 24, 2015; and U.S. patentapplication Ser. No. 10/419,706, filed Apr. 18, 2003.

In some embodiments, the coaptation assistance elements described hereinmay be deployed to overlie the posterior leaflet, the chordae andpapillary muscle. In some embodiments, the coaptation assistance elementattaches superiorly to the posterior aspect of the annulus andinferiorly to the posterior aspect of the left ventricle via annularanchor and/or ventricular anchor. In other embodiments, more than oneannular anchor and/or more than one ventricular anchor may be used toattach the coaptation assistance element. In some elements, the one ormore annular anchors may be replaced by or supplemented with one or moreatrial or commissural anchors, which can be annular in some embodiments.The coaptation assistance element may attach to the superior surface ofthe posterior annulus, the posterior atrial wall, or the annulus itself.A coaptation zone has been established between the coaptation assistanceelement and the native anterior leaflet. Similar coaptation assistanceelements can be used in both functional and degenerative mitral valveregurgitation because the failure of leaflet coaptation occurs in both,regardless of the mechanism behind the dysfunction. In some embodiments,differently sized coaptation assistance elements can be placed such thatthe native anterior leaflet apposes the coaptation element at theappropriately established coaptation point, blocking flow of bloodduring contraction of the ventricle.

A variety of sizes of coaptation assistance elements may be provided,with differing dimensions configured to fit varying anatomies. Forexample, there may be a height, which measures from the superior annularattachment site to the inferior-most edge of the coaptation assistanceelement in a plane basically perpendicular to the plane defined by theannulus of the valve, a depth between the coaptation point and thesuperior attachment site, and a projection between the posterior wall atthe level of the coaptation point and the coaptation point. There isalso a medial-lateral diameter of the coaptation assistance element,typically larger in functional MR. During diastole, the coaptationassistance element may stay in substantially the same position, whilemovement of the native anterior leaflet opens the valve, permitting flowof blood from the left atrium to the left ventricle with minimalrestriction. In some embodiments, the surface of the coaptationassistance element may balloon or stretch upwards during ventricularsystole, while the anchors remain unmoved. This may be advantageous asenhancing the seal between the anterior or coaptation surface of theelement and the native leaflet at the coaptation zone during systole.During diastole, the surface may return to an initial position in whichit lies more anteriorly, toward the anterior leaflet. This may providean improved blood flow path between the atrium and ventricle duringdiastole, improving outflow from the atrium past the coaptation assistelement.

In some methods of use, the native posterior leaflet is left inposition, and the coaptation assistance element is attached superiorlyto the posterior annulus or adjacent atrial wall. Many possiblealternate embodiments may have differing attachment mechanisms. In othermethods of use, the posterior leaflet is not present, having beenremoved surgically or the result of disease. In some methods of use, thenative leaflet attaches to the posterior surface of the coaptationassistance element. In some methods of use, the coaptation assistanceelement may attach to the anterior surface of the posterior leaflet,rather than the annulus or atrial wall. These are some examples ofvariations, but still others are contemplated. In some methods of use,an anchoring structure (not shown) could pass from the coaptationassistance element, through the atrial wall into the coronary sinus,wherein the anchoring structure attaches to a mating structure in thecoronary sinus. In some methods of use, the anchoring structure, whichcould be a mechanical structure or a simple suture, can pass through theatrial wall and be anchored by a knot or mechanical element, such as aclip, on the epicardial surface of the heart. Similarly, attachmentinferiorly may be to the ventricular muscle, through the apex into theepicardium or pericardium and secured from outside, or at otherattachment sites using alternative attachment means.

The coaptation assistance element described herein may exhibit a numberof desirable characteristics. Some embodiments need not rely onreshaping of the mitral annulus (such as by thermal shrinking of annulartissue, implantation of an annular ring prosthesis, and/or placement ofa cinching mechanism either above or beneath the valve plane, or in thecoronary sinus or related blood vessels). Advantageously, they also neednot disrupt the leaflet structure or rely on locking together or fusingof the mitral leaflets. Many embodiments can avoid reliance onventricular reshaping, and after implantation represent passiveimplanted devices with limited excursion which may result in very longfatigue life. Thus, the coaptation assistance element can be securedacross a posterior leaflet while otherwise leaving native heart (e.g.,ventricular, mitral annulus, etc.) anatomy intact.

Mitigation of mitral valve mal-coaptation may be effective irrespectiveof which leaflet segment(s) exhibit mal-coaptation. The treatmentsdescribed herein will make use of coaptation assistance elements thatare repositionable during the procedure, and even removable aftercomplete deployment and/or tissue response begins or is completed, oftenwithout damaging the valve structure. Nonetheless, the coaptationassistance element described herein may be combined with one or moretherapies that do rely on one or more of the attributes described aboveas being obviated. The coaptation assistance element can exhibit benigntissue healing and rapid endothelialization which inhibits migration,thromboembolism, infection, and/or erosion. In some cases, thecoaptation assistance element will exhibit no endothelialization but itssurface will remain inert, which can also inhibit migration,thromboembolism, infection and/or erosion.

FIGS. 5A-5B show two views of an embodiment of a coaptation assistanceelement 500. The coaptation assistance element 500 can include a firstsurface 505 disposed toward a mal-coapting native leaflet, in theinstance of a mitral valve, the posterior leaflet and a second surface515 which may be disposed toward the anterior leaflet. The secondsurface 515 can include a coaptation surface 560. The superior edge 540of the coaptation assistance element 500 may be curved to match thegeneral shape of the annulus or adjoining atrial wall, as describedherein. The superior edge 540 can be curved downward, toward theposterior leaflet, as shown in FIG. 5A, or curved upward, toward theatrial wall to match the general shape of the left atrial wall, as shownin FIG. 6 and described herein.

The coaptation assistance element 500 can have a geometry which permitsit to traverse the valve between attachment sites in the atrium andventricle. In some embodiments, the attachment sites are only in theatrium. In some embodiments, the attachment sites are only near theannulus and the commissures of the valve. The coaptation assistanceelement 500 can be unattached near the inferior edge 580. The coaptationassistance element 500 does not require ventricular attachment. In someembodiments, the geometry of the coaptation assistance element 500 helpsto maintain the position of the coaptation assistance element 500 withinthe valve. In some embodiments, the coaptation assistance element 500 iscurved to cup the posterior leaflet. In some embodiments, the coaptationassistance element 500 is curved backwards toward the superior edge 540.The coaptation assistance element 500 may provide the coaptation surface560 for the anterior leaflet to coapt against. FIGS. 5A and 5Billustrate that geometry.

In some methods of use, the posterior leaflet can be left intact. Thecoaptation assistance element 500 may attach to the atrium or annulussuch that it effectively seals off the posterior leaflet. In somemethods of use, the posterior leaflet can be removed. The coaptationassistance element 500 may, in the instance that the leaflet is or hasbeen removed, replace the posterior leaflet. In some embodiments, thecoaptation assistance element 500 only requires annular attachment. Insome embodiments, the coaptation assistance element 500 only requiresattachment at a single point. The single point may be a central locationof the coaptation assistance element 500, for instance, acentrally-located hub. In some embodiments, the coaptation assistanceelement 500 may attach to the atrium or annulus along an edge. In someembodiments, the coaptation assistance element 500 may attach to theatrium or annulus at a location separated from the edge of thecoaptation assistance element 500, for instance, at a centrally-locatedhub.

The coaptation assistance element 500 can include an annular hub 520engaging an annular anchor 800. The annular anchor 800 may be engaged ata proximal end by a driver, described herein. The annular anchor 800 caninclude a sharpened tip to engage tissue. In some methods of use, thetip of the annular anchor 800 is within the annular hub 520 duringdelivery of the coaptation assistance element 500. In some methods ofuse, the tip of the annular anchor 800 is above the annular section 510during delivery. The tip of the annular anchor 800 can remain recessedwithin the annular hub 520 until the annular anchor 800 is rotated toengage tissue. In some embodiments, the coaptation assistance element500 can be assembled extra-corporeally, engaging the annular anchor 800to the coaptation assistance element 500 via the annular hub 520 and thedrivers to the annular anchor 800. The drivers can then be withdrawninto a delivery catheter, with the coaptation assistance element 500 ina collapsed position. The drivers may be separately manipulated by theoperator to place the annular anchor 800 in the appropriate position.Alternatively, the annular anchor 800 may be engaged to the coaptationassistance element 500 and/or the driver sequentially, either before orafter deployment through the delivery catheter. The coaptationassistance element 500 after placement can entirely cover the posteriorleaflet so that the coaptation assistance element 500 coapts with theanterior leaflet during systole and, with the native anterior leaflet,maintains the valve seal at the annular ring.

In some embodiments, the annular anchor 800 is an active anchor. Theuser can selectively engage or disengage the annular anchor 800 fromtissue. Unlike barbs or other passive anchors, an active anchor can beactivated such as by rotation in order to engage tissue. The annularanchor 800 allows placement of the coaptation assistance element 500prior to engagement of the annular anchor 800. The coaptation assistanceelement 500 can make contact with the tissue without any adhesion of theannular anchor 800. In some embodiments, the annular anchor 800 andcorresponding hub 520 are centrally located on the coaptation assistanceelement 500. The annular anchor 800 and corresponding hub 520 are spacedapart from any edge of the coaptation assistance element 500. Thelocation of the annular anchor 800 and corresponding hub 520 can be at aneutral center to prevent swinging of the coaptation assistance element500 when the coaptation assistance element 500 is held by the annularhub 520. The corresponding hub 520 provides a convenient location tohold and move the coaptation assistance element 500.

The annular hub 520 may have a built-in or coupled annular anchor 800.In some embodiments, the annular anchor 800 can be retained by across-pin, described herein, within the annular hub 520. The cross-pinmay pass through the helical structure of the annular anchor 800 toprevent dislodgement of the annular anchor 800 from the annular hub 520by a blunt force. The annular anchor 800 may comprise a helix rotatablewith respect to the annular hub 520. In some embodiments, other anchorsmay be used. The annular anchor 800 may be in the form of a tether orother attachment means extending from the coaptation assistance element500 thru the ventricle septum to the right ventricle. The annular anchor800 may be in the form of a tether or other attachment means extendingthru the apex into the epicardium or pericardium. The annular anchor 800may be secured from outside the heart in and combined endo/epiprocedure. When helical anchors are used, they may comprise bio-inertmaterials such as Platinum/Ir, a Nitinol alloy, and/or stainless steel.

In some embodiments, the coaptation assistance element 500 can include asingle central annular anchor 800 inside the annular hub 520. Thecoaptation assistance element 500 can be delivered percutaneously asdescribed herein by attachment of a delivery catheter to the annular hub520. The coaptation assistance element 500 can be configured foradjustable positioning by removing and reattachment of the annularanchor 800. The coaptation assistance element 500 can be recapturable byremoval of the annular anchor 800 and withdrawal of the coaptationassistance element 500. The coaptation assistance element 500, may alsoinclude secondary anchors including commissural anchors, ventricularanchor, annular anchors, barbs, tethers or any other known fixationdevice.

As may be seen in FIGS. 5A-5B, the coaptation assistance element 500 caninclude a plurality of struts 530. In some embodiments, one or more ofthe struts 530 have one end terminating at the hub 520 and the other endextending radially outwardly toward one of the superior edge 540, thelateral edges 570 and 575, and the inferior edge 580 of the coaptationassistance element 500. The struts 530 may extend outward in variousdirections from the hub 520, and can be spaced apart from adjacentstruts 530 at regular or irregular intervals. In some embodiments,adjacent struts 530 extend outward from the hub at an angle of betweenabout 5 degrees and about 45 degrees, between about 10 degrees and about30 degrees, or about 5, 10, 15, 20, 25, or 30 degrees with respect to anadjacent strut 530. The struts 530 may be arranged generally parallel tothe longitudinal axis of the coaptation assistance element 500 to assistin maintaining the shape of the coaptation assistance element 500 uponplacement. The struts 530 may allow the coaptation assistance element500 to assume a reduced configuration for deployment through a catheter.In some embodiments, the struts 530 that form a portion of thecoaptation zone of the implant 500 have a maximum length that is greaterthan struts 530 that only form a portion of the annular zone of theimplant. In some embodiments, the struts 530 that form a portion of thecoaptation zone of the implant can be, for example, at least about 10%,20%, 30%, 40%, 50%, 75%, 100%, 125%, or 150% longer than the struts 530that form a portion of the annular zone of the implant.

FIG. 5A shows a view of the coaptation assistance element 500 with anannular anchor site 535. The annular anchor site 535 can be a portion ofthe struts 530. The annular anchor site 535 is shown extending downwardfrom the coaptation assistance element 500 in FIG. 5A. In otherembodiments, the annular anchor site 535 may extend in other directionsfrom the coaptation assistance element 500 to engage tissue. In someembodiments, the annular anchor site 535 comprises one or more barbshaving a sharpened tip. The annular anchor site 535 may be a passiveanchor.

In some embodiments, the coaptation assistance element 500 can includeone or more retractable barbs. For instance, the barbs can be retractedduring delivery of the coaptation assistance element 500. For instance,the barbs can be advanced after the coaptation assistance element 500 ispositioned relative to the anatomical structures. In some embodiments,the barbs are actively retracted and/or advanced. For instance, thedelivery catheter described herein can include a mechanism coupled tothe barbs designed to retract and/or advance the barbs. In otherembodiments, the barbs are passively advanced and/or retracted. In someembodiments, the coaptation assistance element 500 is delivered with thebarbs in a retracted state. In some embodiments, the barbs can becovered by the valve body covering as described herein. In someembodiments, the interface between the tissue and the valve bodycovering pushes back the valve body covering and exposes the barbs. Insome embodiments, the tissue dissolves and/or absorbs a portion of thevalve body covering and exposes the barbs. In some embodiments, themotion of the purse-string suture, described herein, advances the barbs.In some embodiments, the motion of the purse-string suture causes motionof the valve body covering to expose the barbs. Other configurations arecontemplated.

The annular anchor site 535 may define a diameter D1 shown in FIG. 5B,which may in some embodiments correspond to the distance between themedial and lateral commissures of the native valve or theintracommissural distance (ICD). D1 may range between 20-60 mm with, insome embodiments, a preferred length between 35-45 mm, as correspondingmost closely to the widest range of human mitral ICD. In someembodiments, D1 may be the distance from the right to left fibroustrigones.

The coaptation assistance element 500 can include a generally annularsection 510. The annular section 510 can be positioned above the nativeleaflets when the coaptation assistance element 500 is deployed. In someembodiments, the annular section 510 may be curved toward the annulus orcurved away from the annulus. The annular section 510 can be concave. Inother embodiments, the annular section 510 may be substantially flatwith respect to the annulus. One or more of the struts 530 may curvelaterally from the hub 520 toward the superior edge 540 to assist inmaintaining the shape of the annular section 510 of the coaptationassistance element 500 upon deployment. The coaptation assistanceelement 500 can curve downward from the hub 520 toward the annularanchor site 535. In some embodiments, the coaptation assistance element500 does not rest against the posterior leaflet. In some embodiments,the annular anchor site 535 is the only point of contact between theposterior annulus of the mitral valve and the coaptation assistanceelement 500. The superior edge 540 can include an annular radius ofcurvature. The annular curve radius can curve toward the annulus. Theannular curve radius can curve toward the coaptation surface 560. Insome embodiments, the annular curve radius can be between 0 mm-5 mm, 5mm-10 mm, 10 mm-15 mm, 15 mm-20 mm, 20 mm-25 mm, 25 mm-30 mm, etc.

The struts 530 may be composed of a radio-opaque material. In someembodiments, the struts 530 are composed of resiliently deformablematerials such as a shape memory metal, e.g., Nitinol or a shape memorypolymer. In some embodiments, the material is Elgiloy. In otherembodiments, the struts 530 may be composed of other materials toinclude stainless steel, polypropylene, high density polyethylene (PE),Dacron, acellular collagen matrix such as SIS, or other plastics, etc.In other embodiments, the struts 530 may be a combination such as a highdensity PE sheath around a core of ePTFE, Dacron, and/or polypropylene.The struts 530 may have a circular cross section, an oval cross section,or be ribbon-like. In some embodiments, the struts 530 are coiledsprings or zig-zag shaped. The struts 430 may have a constant stiffness.In some embodiments, one or more struts 530 can have differing stiffnessalong the length of the one or more struts 530. The struts 530 may bestiffer at the annular end than at the ventricular end of the coaptationassistance element 500. The struts 530 may be less stiff at the annularend than at the ventricular end of the coaptation assistance element500. The struts 530 may be stiffer at a midpoint, for instance at aninflection point or curve. The struts 530, along with one or more othersupport structures, can form a frame. In some embodiments, one or moresupport structures may be provided which run parallel to the superioredge 540 of the coaptation assistance element 500 and assist inmaintaining the shape of the superior edge 540. The struts 530 and/orother support structures of the frame can be laser-cut from a Nitinoltube in some embodiments.

The coaptation assistance element body covering 550 may be comprised ofa material such as ePTFE. Other materials for the coaptation assistanceelement body covering 550 include polyester, polyurethane foam,polycarbonate foam, biologic tissue such as porcine pericardium,processed bovine pericardium, pleura, peritoneum, silicone, Dacron,acellular collagen matrix, etc. In some embodiments, the coaptationassistance element body covering 550 can include a foam materialsurrounded by ePTFE. Use of sponge or foam material enhances thecapability of having the coaptation assistance element 500 to fold to asmall enough diameter to pass through a catheter. In some embodiments,the coaptation assistance element body covering 550 has no pores. Inother embodiments, the coaptation assistance element body covering 550may have micropores to enhance endothelialization and cellularattachment. The coaptation assistance element body covering 550 may alsoincorporate a radiopaque material or an echo-enhancement material forbetter visualization. Any support structures of the coaptationassistance element 500 including the struts 530 or support interfaceincluding the hub 520 may be coated with radio-opaque materials such asgold or platinum or impregnated with barium. The coaptation surface 560may be coated with an echo enhancement material. The coaptationassistance element body covering 550 may be coated with a material toinhibit thrombosis, such as heparin bonding or quinoline and quinoxalinecompounds, or with a material to accelerate endothelialization, or withantibiotic to inhibit infection. In some embodiments, the purse-stringsuture 1010 described herein can incorporate a radiopaque material or anecho-enhancement material for better visualization.

In some embodiments, the struts 530 may be sandwiched between layers ofcoaptation assistance element body covering 550. The coaptationassistance element body covering 550 may be composed of the samematerial on the first surface 505 and the second surface 515. Thecoaptation assistance element body covering 550 may be composed ofdifferent materials on the first surface 505, or a portion thereof, andthe second surface 515, or a portion thereof. In some embodiments, thestruts 530 may be attached to or embedded in the first surface 505 orthe second surface 515 of a single layer of coaptation assistanceelement body covering 550. In some embodiments, the struts 530 may be“stitched” through the coaptation assistance element body covering 550.The annular anchor site 535 can be exposed ends of the struts 530 fromthe coaptation assistance element body covering 550.

The coaptation assistance element 500 can include a purse-string suture1010. The purse-string suture 1010 can extend along a portion of thecoaptation assistance element 500. The purse-string suture 1010 canextend along the superior edge 540, or a portion thereof. Thepurse-string suture 1010 can extend along the lateral edge 570, or aportion thereof. The purse-string suture 1010 can extend along thelateral edge 575, or a portion thereof. The purse-string suture 1010 canextend along the inferior edge 580, or a portion thereof. Thepurse-string suture 1010 can extend along a perimeter, or a portionthereof, of the coaptation assistance element 500. The purse-stringsuture 1010 can extend along one or more struts 530. The purse-stringsuture 1010 can extend in a linear path, a non-linear path, a curve, asemi-circle or any open or closed shape.

In some embodiments, the purse-string suture 1010 may be sandwichedbetween layers of valve body covering 550. For instance, thepurse-string suture 1010 can be disposed in a lumen between layers ofcoaptation assistance element body covering 550. In some embodiments,the purse-string suture 1010 may be attached to or embedded in the firstsurface 505 or the second surface 515 of a single layer of valve bodycovering 550. In some embodiments, the purse-string suture 1010 may be“stitched” through the coaptation assistance element body covering 550.The purse-string suture 1010 can pass from the first surface 505 to thesecond surface 515 and back to the first surface 505. The purse-stringsuture 1010 can include one or more exposed ends from the coaptationassistance element body covering 550. In embodiments where thepurse-string suture 1010 is a loop, the purse-string suture can includeone or more exposed sections of the loop from the valve body covering.

The coaptation assistance element 500 may be collapsed by tightening thepurse-string suture 1010. The coaptation assistance element 500 may beexpanded by loosening the purse-string suture 1010. The one or moreexposed ends or loops can be manipulated by a delivery catheter or othertool to tighten or loosen the purse-string suture 1010. The ability tocollapse or expand the coaptation assistance element 500 may bebeneficial for recapture of the coaptation assistance element 500 and/orrepositioning of the coaptation assistance element 500.

The coaptation assistance element 500 may be rotated by tightening oneor more purse-string suture 1010 and/or loosening one or morepurse-string suture 1010. For instance, tightening one or morepurse-string suture 1010 on the lateral edge 570 and/or loosening one ormore purse-string suture 1010 on the lateral edge 575 may cause thecoaptation assistance element 500 to rotate. One or more purse-stringsutures 1010 may be coupled to the coaptation assistance element 500 toenable multi-directional rotation.

The coaptation assistance element 500 may be expanded by loosening thepurse-string suture 1010. The one or more exposed ends or loops can bemanipulated by a delivery catheter or other tool to tighten or loosenthe purse-string suture 1010. The ability to collapse or expand thecoaptation assistance element 500 may be beneficial for recapture of thecoaptation assistance element 500 and/or repositioning of the coaptationassistance element 500.

The coaptation surface 560 of the coaptation assistance element 500 maybe adjusted by motion of the purse-string suture 1010. The one or moreexposed ends or loops can be manipulated by a delivery catheter or othertool to tighten or loosen the purse-string suture 1010 to change thecurvature of the coaptation surface 560 in situ. The ability to adjustthe curvature of the coaptation assistance element 500 may be beneficialto conform to the geometry of heart including the geometry of theanterior leaflet.

The annular dimension of the coaptation assistance element 500 may beadjusted by motion of the purse-string suture 1010. The one or moreexposed ends or loops can be manipulated by a delivery catheter or othertool to tighten or loosen the purse-string suture 1010 to change one ormore dimensions of the coaptation assistance element 500 in situ. Theability to adjust dimensions of the coaptation assistance element 500may be beneficial to conform to the geometry of the heart.

The coaptation assistance element 500 can include one or morepurse-string sutures 1010. In some embodiments, the coaptationassistance element 500 includes one purse-string suture, twopurse-string sutures, three purse-string sutures, four purse-stringsutures, five purse-string sutures, six purse-string suture, sevenpurse-string sutures, eight purse-string sutures, nine purse-stringsutures, ten purse-string sutures, etc. For instance, a purse-stringsuture 1010 can extend along each edge of the coaptation assistanceelement 500. When multiple purse-string sutures are provided, thepurse-string sutures 1010 can act together to change the configurationof the coaptation assistance element 500. When multiple purse-stringsutures are provided, the purse-string sutures 1010 can actindependently to change the configuration of the coaptation assistanceelement 500.

FIG. 5A further illustrates a coaptation element height, correspondingto the distance between the inferior edge 580 and the annular hub 520 asmeasured perpendicular to the plane defined by the annulus of the valve.Coaptation element height of some embodiments may be 10-80 mm, with someembodiments ranging between 40-55 mm. The coaptation element height canbe between 10-20 mm, 20-30 mm, 30-40 mm, 40-50 mm, 50-60 mm, 60-70 mm,70-80 mm, etc.

FIG. 5A illustrates the generally triangular shape of coaptationassistance element 500, such that the coaptation assistance element 500has a superior edge 540, lateral edges 570 and 575, and inferior edge580. In some embodiments, the superior edge 540 has a length greaterthan that of inferior edge 580, such that the transverse distancebetween lateral edges 570 and 575 generally decreases from superior toinferior on the coaptation assistance element 500. For example, thelength of the superior edge 540 may be in the range of 15-50 mm, or25-35 mm, while the length of the inferior edge 580 may be in the rangeof 1-15 mm, or 2-6 mm.

The annular hub 520 may be a hub, an eyelet, or any other tether siteknown in the art. In some embodiments, the annular hub 520 is located ata midpoint of the distance D1. In some embodiments, the annular hub 520is located at a neutral center to prevent swinging of the coaptationassistance element 500 when the coaptation assistance element 500 isheld by the annular hub 520. In other embodiments, the annular hub 520is located at one of the commissures. While only one annular anchor 800is shown, in other embodiments, two or more annular hubs 520 may beprovided.

In some embodiments, the struts 530 can comprise NiTi tubing. In someembodiments, the struts 530 can be laser cut from the tubing. In someembodiments, the frame including one or more struts 530 and/or one ormore support structures can be laser cut from a single piece ofmaterial. In some embodiments, the frame including one or more struts530, the annular hub 520, and/or one or more support structures can beintegrally formed. In some embodiments, the coaptation assistanceelement body covering 550 comprises ePTFE lamination. The lamination cansurround one or more of the struts 530 and/or one or more supportstructures (e.g., one side, two sides, first side 505, second side 515).The struts 530 and/or one or more support structures can be encased bytwo or more layers of lamination. The perimeter of the annular section510 of the coaptation assistance element 500 can be cupped down. Theperimeter of the annular section 510 of the coaptation assistanceelement 500 can be cupped up. The perimeter of the annular section 510of the coaptation assistance element 500 can include secondary anchorssuch as the annular anchor site 535.

In some embodiments, the annular anchor 800 and the annular hub 520 forma single central anchor system. In some embodiments, the coaptationassistance element 500 is affixed to the tissue by only one annularanchor 800 which passes through the hub 520. In other embodiments,additional fixation is included. In some embodiments, the coaptationassistance element 500 is affixed to the tissue by the one anchor 800which passes through the hub 520 and the annular anchor site 535 asdescribed herein. The system can include features to allow rotationaladjustment of the coaptation assistance element 500. For instance, thehub 520 and/or the annular anchor 800 can be coupled to the deliverycatheter to allow the transmission of axial movement and/or torque. Thecoaptation assistance element 500 can be immovably grasped by a deliverycatheter such that rotation of a feature of the delivery catheter, suchas a handle, causes rotation of the coaptation assistance element 500.The coaptation assistance element 500 can be immovably grasped by adelivery catheter such that axial movement of a feature of the deliverycatheter, such as a drive shaft, causes axial movement of the coaptationassistance element 500.

In some embodiments, the hub 520 is located at a neutral position on thecoaptation assistance element 500. The neutral position can be a centrallocation on the annular section 510. The neutral position can be betweenthe lateral edges 505, 515. The neutral position can be between thesuperior edge 540 and the cooptation surface 560. The neutral positioncan enhance stability of the coaptation assistance element 500 when thecoaptation assistance element 500 is grasped at a single location suchas the hub 520 and/or the annular anchor 800. The neutral position canbe aligned with a structure of the mitral valve. The neutral positioncan be aligned along the coaptation zone.

In some embodiments, the coaptation assistance element 500 is deliveredpercutaneously as described herein. In some embodiments, the coaptationassistance element 500 is adjustable via a delivery catheter. Forinstance, the coaptation assistance element 500 can be expanded and/orcollapsed by the delivery catheter. For instance, the coaptationassistance element 500 can be rotated about a fixed position of theannular hub 520. For instance, the coaptation assistance element 500 canbe recapturable. For instance, the coaptation assistance element 500 canbe engaged and reengaged by the delivery catheter. For instance, theannular anchor 800 can be disengaged from the tissue and the deliverycatheter can recapture the coaptation assistance element 500.

FIGS. 5C-5D illustrate embodiments of a frame 565 of the coaptationassistance element 500. These figures illustrated the flattened patternsof the frame 565 prior to bending and/or shape setting. In someembodiments, the frame 565 is cut from a tubular stock. In otherembodiments, the frame 565 is cut from flat stock such as a flat sheetof material. The frame 565 including portions thereof can be laser cut.The frame 565 can include one or more struts 530. In the embodimentshown in FIG. 5D, the frame 565 includes twenty struts 530 but otherconfigurations are contemplated (e.g., one strut, two struts, threestruts, four struts, five struts, between five and ten struts, betweenten and fifteen struts, between fifteen and twenty struts, betweentwenty and twenty-five struts, between twenty-five and thirty struts,etc.).

In some embodiments, one or more struts 530 are coupled to a backing585. In some embodiments, the backing 585 is transverse to the directionof the struts 530. In the illustrated embodiment, the backing 585 isvertical or generally vertical and the struts 530 are horizontal orgenerally horizontal. In some embodiments, the backing 585 is theannular hub 520. For instance, the two ends of the backing 585 can bejoined using methods known in the art to form the annular hub 520. Thetwo ends are joined, for instance, if the frame 565 is cut from flatstock. In other embodiments, the frame 565 is formed from tubular stock.The backing 585 can be a portion of uncut tubular stock. The two ends ofthe backing 585 may not need to be joined if the frame 565 is formedfrom tubular stock. The uncut tubular stock can form the annular hub520. The patters of the frame 565 as shown in FIG. 5D can be cut fromtubular stock, thereby eliminating the need to join the two ends of thebacking. Other modes of manufacturing are contemplated to form the frame565. In other embodiments, the backing 585 forms at least a portion ofthe annular hub 520. In some embodiments, the backing 585 surrounds atleast a portion of the annular hub 520. In some methods ofmanufacturing, the backing 585 can be formed into a shape of a circle.In some methods of manufacturing, the struts 530 extend radially outwardfrom the backing 585 once the backing 585 is shaped into a circle. Thebacking 585 can include one or more openings designed to accept across-pin, as disclosed herein. In some methods of manufacturing, thebacking 585 is removed.

Referring to FIGS. 5A and 5C, a plurality of struts 530 can extend fromthe annular hub 520 to the inferior end 580. In some embodiments, thesestruts 530 are longer than other struts 530 of the frame 565. In someembodiments, the struts 530 might include an anchor or barb thatinteracts with the subvalvular structure, including the ventricularwall. In some embodiments, these struts engage the posterior leaflet oranother anatomical structure. In some embodiments, the ventricularanchoring is passive.

Referring to FIG. 5A-5D, a plurality of struts 530 can extend from theannular hub 520 to the superior end 540. In some embodiments, thesestruts 530 are shorter than other struts 530 of the frame 565. In someembodiments, these struts 530 form an atrial anchor and/or the annularanchor site 535 described herein. In some embodiments, these strutsengage the annulus or another anatomical structure. In some embodiments,the annular anchoring is passive.

Referring to FIGS. 5A and 5D, a plurality of struts 530 can extend fromthe annular hub 520 to the lateral edges 570 and 575. In someembodiments, these struts 530 have a mid-length between the ventricularstruts and the atrial struts. In some embodiments, these struts engagethe commissures or another anatomical structure. In some embodiments,the commissural anchoring is passive.

The struts 530 can have a variety of lengths based on the desired shapeof the coaptation assistance element 500. As shown in FIGS. 5C-5D, twoor more struts 530 have a different length. As shown in FIGS. 5C-5D, twoor more struts 530 have the same length. FIG. 5C shows a schematic modelof the frame 565. One or more of the top three struts can form thecoaptation surface 560 and extend to the inferior edge. One or more ofthe bottom three struts can form the annular portion and extend to thesuperior edge. The struts 530 can be laser-cut from a tube. The lengthcan be measured from the annular hub 520 to an edge of the coaptationassistance element 500. The range of the strut length can be 1 mm to 50mm. The range of the strut length can be 5 mm to 35 mm for the annularportion 510. The strut length can be about 15 mm for the annular portion510. The range of the strut length can be 20 mm to 35 mm for thecoaptation surface 560. The strut length can be about 30 mm for thecoaptation surface 560. Other configurations of the range of strutlength are contemplated e.g., 5 mm to 45 mm, 10 mm to 40 mm, 15 mm to 35mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm,about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about55 mm, about 60 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mmto 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc.

The width can be measured perpendicular to the strut length. The rangeof the strut width can be 0.1 mm to 2 mm. One or more struts can have anouter diameter or width of about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm,0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm,1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 0.5 mm, lessthan 1 mm, less than 1.5 mm, less than 2 mm, etc. One or more struts 530can have a varying width along the strut length. In some embodiment, oneor more struts 530 taper near an edge of the coaptation assistanceelement 500. In some embodiments, one or more struts 530 taper near theannular hub 520. The one or more struts 530 can include a reduceddiameter or taper at the connection between the one or more struts 530the annular hub 520. The taper near the annular hub 520 can aid incollapsing the coaptation assistance element 500. The taper near theannular hub 520 can facilitate insertion of the coaptation assistanceelement 500 into the delivery catheter. The taper can reduce stressand/or strain in the strut 530 during collapse. In some embodiments, thetaper can aid in longer fatigue life. In some embodiments, one or morestruts 530 include a varying width taper. The width of the strut 530 canvary along the length of the strut 530. One or more struts 530 caninclude eyelets along the length of the strut 530. In some embodiments,the eyelets can reduce stress of the struts 530. In some embodiments,the eyelets can facilitate adhesion between the strut 530 and the valvebody covering 550.

The thickness can be measured perpendicular to the strut length andstrut width. The thickness can be determined by the thickness of thematerial of the frame, as described herein. The range of the strutthickness can be 0.2 mm to 0.5 mm. One or more struts can have athickness of about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 0.5 mm, less than 1 mm, lessthan 1.5 mm, less than 2 mm, etc.

One or more the struts 530 can include barbs. In some embodiments, thebarbs can be configured for placement near the ventricular end of thecoaptation assistance element 500. In some embodiments, the barbs can bebent out of the plane of the strut 530. In some embodiments, the barbcan have a bayonet configuration. In some embodiments, the barbs canhave a sharpened tip. In some embodiments, one or more struts 530 can bebifurcated. In some embodiments, one or more struts 530 can include oneor more zigzag sections. In some embodiments, the zigzag section reducesstress and/or increases flexibility of the strut 530. In someembodiments, the zigzag section facilitates adhesion between the strut530 and the coaptation assistance element body covering 550.

In some embodiments, one or more struts 530 can include supplementalbarbs. In some embodiments, the supplemental barbs can be bent out ofthe plane of the strut 530. In some embodiments, one or more portions ofthe strut length are bent out of the plane of the strut. For instance, aportion of the strut can be twisted or bent during manufacturing. Insome embodiments, the portion that is bent out of plane is shaped toengage tissue. In some embodiments, one or more struts 530 can includeincreased widths to compensate for electropolishing or other postmanufacturing processes. In some embodiments, the backing 585 caninclude one or more features to engage the delivery catheter describedherein. In some embodiments, the backing 585 can include one or morenotches designed to interface with a locking tab or other feature of thedelivery catheter as described herein. In some embodiments, one or morestruts 530 can include a greater width than other struts 530. In someembodiments, the frame 565 includes two or more struts 530 that have agreater width than other struts 530. The two or more struts 530 canfacilitate visualization of the coaptation assistance element 500. Insome embodiments, the two or more struts 530 that have a greater widthare designed to be placed near the commissures when the coaptationassistance element 500 is deployed. In some embodiments, one or morestruts 530 can have smaller width compared with one or more otherstruts. In some embodiments, each strut 530 has the same width near theannular hub 520. The backing 585 can be modified to interface with thedelivery catheter, as described herein. The backing 585 can be designedto allow independent rotation of the anchor 800 within the hub of thecoaptation assistance element 500.

FIGS. 5E, 5F, and 5G show an embodiment of the coaptation assistanceelement 500 without barbs. FIG. 5E shows a schematic perspective view ofthe coaptation assistance element 500. FIG. 5F shows a schematicperspective view of the first surface 505 disposed toward a mal-coaptingnative leaflet. FIG. 5G shows a schematic cross-sectional view includingthe anchor 800.

FIGS. 5H, 5I, and 5J show an embodiment of the coaptation assistanceelement 500 with leaflet anchor sites 545. As shown in FIG. 5A, theannular anchor sites 535 such as barbs can extend along an edge of thecoaptation assistance element 500. FIGS. 5H, 5I, and 5J show anembodiment of the coaptation assistance element 500 with leaflet anchorsites 545 extending from the first surface 505 disposed toward amal-coapting native leaflet.

FIG. 5H shows a schematic perspective view of the coaptation assistanceelement 500 including an enlarged section showing the leaflet anchorsites 545. FIG. 5I shows a schematic perspective view of the firstsurface 505 disposed toward a mal-coapting native leaflet. FIG. 5J showsa schematic cross-sectional view including the anchor 800.

In some embodiments, the leaflet anchor sites 545 comprise one or morebarbs having a sharpened tip. The leaflet anchor sites 545 may be apassive anchor. In some embodiments, the coaptation assistance element500 can include one or more retractable barbs. For instance, the leafletanchor sites 545 can be retracted during delivery of the coaptationassistance element 500. For instance, the leaflet anchor sites 545 canbe advanced after the coaptation assistance element 500 is positionedrelative to the anatomical structures. In some embodiments, the leafletanchor sites 545 are actively retracted and/or advanced. For instance,the delivery catheter described herein can include a mechanism coupledto the leaflet anchor sites 545 designed to retract and/or advance thebarbs. In other embodiments, the leaflet anchor sites 545 are passivelyadvanced and/or retracted. In some embodiments, the leaflet anchor sites545 can be covered by the valve body covering as described herein. Insome embodiments, the interface between the tissue and the valve bodycovering pushes back the valve body covering and exposes the leafletanchor sites 545. In some embodiments, the tissue dissolves and/orabsorbs a portion of the valve body covering and exposes the leafletanchor sites 545. In some embodiments, the motion of the purse-stringsuture, described herein, advances the leaflet anchor sites 545. In someembodiments, the motion of the purse-string suture causes motion of thevalve body covering to expose the leaflet anchor sites 545. Otherconfigurations are contemplated.

One or more struts 530 may have one or more barbs along the length ofthe strut 530. In the illustrated embodiment, five struts 530 each havefour leaflet anchor sites 545 along the length of the struts. Otherconfigurations are contemplated varying the number of struts 530 (e.g.,one strut, two struts, three struts, four struts, five struts, sixstruts, seven struts, eight struts, nine struts, ten struts, etc.) andvarying the number of leaflet anchor sites 545 per strut 530 (e.g., onebarb, two barbs, three barbs, four barbs, five barbs, six barbs, sevenbarbs, eight barbs, nine barbs, ten barbs, etc.). One or more struts 530can have the same number of leaflet anchor sites 545. Two or more struts530 can have a different number of leaflet anchor sites 545. The leafletanchor sites 545 can be disposed to engage the posterior leaflet.

In some embodiments, the struts 530 may be sandwiched between layers ofvalve body covering 550. In some embodiments, the struts 530 may beattached to or embedded in the first surface 505 or the second surface515 of a single layer of valve body covering 550. In some embodiments,the struts 530 may be “stitched” through the valve body covering 550.The first surface 505 can include one or more openings for the leafletanchor sites 545. In other embodiments, the leaflet anchor sites 545 canpush through the valve body covering 550. The leaflet anchor sites 545can have a pre-set curve which can exert a force on the first surface505. The leaflet anchor sites 545 can be sharpened to cut through thevalve body covering 550.

The frame 565 can have many advantages. The frame 565 can be formed froma flattened pattern. The frame 565 can include an edge which forms theannular hub 520. The edge can include a longitudinal strip or backing585. One or more struts 530 can extend from the backing 585. In theillustrated embodiment of FIGS. 5C and 5D, the one or more struts 530are perpendicular to the longitudinal strip. The struts 530 aregenerally parallel. In some embodiments, the struts 530 are generallyperpendicular to the backing 585 that forms the annular hub 520. In someembodiments, the struts 530 form an angle with the backing 585. Forinstance, the longitudinal axis of the struts 530 can form an acuteangle with the backing 585. The angle can aid in the collapse of thestruts 530 into the delivery catheter.

The frame 565 can be constructed from a single, planar sheet ofmaterial. The frame 565 can be precisely cut using water jet, laseretching or similar technology. The details of the struts 530, includingbarbs, can be machined into the struts 530. The frame 565 can be bentand/or shape set to achieve the desired geometry. In some embodiments,the backing 585 is folded to form a loop. The frame 565 can be rolledinto a tubular shape. The backing 585 can be welded or otherwisesecured. The backing 565 when secured end to end to form a loop can beconsidered the annular hub 520.

The struts 530 are bent to the desired configuration. The struts 530 canform one or more curves. The struts 530 can have one or more inflectionpoints. The struts 530 can have concave portions and/or convex portions.One or more struts 530 can include a radially outward flare beginning atan inflection point. In some embodiments, the superior edge 540 iscurved upward away from the inferior edge 580. In some embodiments, thesuperior edge 540 is curved downward toward the inferior edge 580. Insome embodiments, one or more struts 530 can be substantially flat. Thestruts 530 near the commissures can be substantially flat. In someembodiments, the inferior edge 580 is curved backward toward thesuperior edge 540. In some embodiments, the inferior edge 580 is curvedforward away from the superior edge 540.

The struts 530 can be equally spaced about the circumference of theannular hub 520. The struts 530 can be unequally spaced about thecircumference of the annular hub 520. The struts 530 extending along aportion of the circumference of the annular hub 520 are different thanstruts extending along another portion of the circumference of theannular hub 520. One or more designated portions of the struts 530 canbe designed to be placed near the annular region of the heart. One ormore designated portions of the struts 530 can be designed to be placednear the commissure region of the heart. One or more designated portionsof the struts 530 can be designed to be placed near the ventricularregion of the heart. The geometry of the radially extending struts 530can be shaped to match the geometry of the patient. In some embodiments,the geometry is patient specific. The operator can shape one or morestruts 530 based on the geometry of the heart. The operator can modifythe shape of one or more struts 530 based on the geometry of thepatient.

FIG. 5K illustrates dimensions of the coaptation assistance element 500.The coaptation assistance element 500 can include a dimension A. Thedimension A can be a linear projected dimension or posterior projection.In some embodiments, the range of dimension A can be 1 mm to 40 mm. Insome embodiments, the range of dimension A can be 4 mm to 24 mm. Otherconfigurations of the range of dimension A are contemplated e.g., 5 mmto 35 mm, 10 mm to 30 mm, 15 mm to 25 mm, about 1 mm, about 2 mm, about3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about9 mm, about 10 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mmto 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. Thedimension A can be 0 mm if no posterior projection, for instance if thecoaptation assistance element 500 is straight.

The coaptation assistance element 500 can include a dimension B. In someembodiments, the dimension B can be a radius of curvature. The radius ofcurvature can be concave or convex, as described herein. In someembodiments, the range of dimension B can be 1/16 inch to ½ inch. Insome embodiments, the range of dimension B can be 1.5 mm to 13 mm. Insome embodiments, the range of dimension B can be ¼ inch to ⅜ inch. Insome embodiments, the range of dimension B can be 6 mm to 9.5 mm. Insome embodiments, the range of dimension B can be 1 mm to 15 mm. Otherconfigurations of the range of dimension B are contemplated e.g., 2 mmto 14 mm, 3 mm to 13 mm, 4 mm to 12 mm, 5 mm to 11 mm, 6 mm to 10 mm, 7mm to 9 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm,about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, 1 mm to 10mm, 5 mm to 15 mm, 10 mm to 20 mm, etc. The dimension B can be 0 mm ifno curvature, for instance if the coaptation assistance element 500 isstraight.

The coaptation assistance element 500 can include a dimension C. In someembodiments, the dimension C can be a radius of curvature near thesuperior edge 540. In some embodiments, the range of dimension C can be1 mm to 10 mm. In some embodiments, the range of dimension C can be 1 mmto 5 mm. Other configurations of the range of dimension C arecontemplated e.g., 2 mm to 9 mm, 3 mm to 8 mm, 4 mm to 7 mm, 5 mm to 6mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, 1 mm to 15 mm, 5 mmto 10 mm, 3 mm to 9 mm, etc. The dimension C can be 0 mm if nocurvature, for instance if the coaptation assistance element 500 isstraight.

The coaptation assistance element 500 can include a dimension D. Thedimension D can be a coaptation element height. The dimension D cancorrespond to the distance between the inferior edge 580 and the atrialanchor site or annular hub 520 as measured perpendicular to the planedefined by the annulus of the valve. In some embodiments, the range ofdimension D can be 10 mm to 80 mm. In some embodiments, the range ofdimension D can be 40 mm to 55 mm. Other configurations of the range ofdimension D are contemplated e.g., 5 mm to 105 mm, 10 mm to 100 mm, 15mm to 95 mm, 20 mm to 90 mm, 25 mm to 85 mm, 30 mm to 80 mm, 35 mm to 75mm, 40 mm to 70 mm, 45 mm to 65 mm, 50 mm to 60 mm, about 10 mm, about20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70 mm,about 80 mm, about 90 mm, about 100 mm, 10 mm to 50 mm, 20 mm to 60 mm,30 mm to 70 mm, 40 mm to 80 mm, 50 mm to 90 mm, 60 mm to 100 mm, 70 mmto 110 mm, etc.

The coaptation assistance element 500 can include a dimension E. Thedimension E can be a linear projected dimension or anterior projection.In some embodiments, the range of dimension E can be 2 mm to 20 mm. Insome embodiments, the range of dimension E can be 5 mm to 10 mm. Otherconfigurations of the range of dimension E are contemplated e.g., 0 mmto 25 mm, 5 mm to 20 mm, 10 mm to 15 mm, about 1 mm, about 2 mm, about 3mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm,about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about20 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. The dimension E can be0 mm if no anterior projection.

The struts 530 of the coaptation assistance element 500 can form aposterior curve of the coaptation surface 560. The posterior bend canhave a bend length of the distal 30-100% of the strut. In someembodiments, the posterior bend can have a bend length of at least thedistal 40% of the strut. The angle of the posterior bend can be in therange of 0 degrees to 90 degrees with respect to the longitudinal axisof the coaptation assistance element 500. In some embodiments, the angleof the posterior bend can be in the range 45 degrees to 90 degrees.

FIG. 6 illustrates an embodiment of a coaptation assistance element 600.The coaptation assistance element 600 can be similar to the coaptationassistance element 500, and include any features of the coaptationassistance element 500 described herein, with certain additionalfeatures described below.

The coaptation assistance element 600 can include an annular hub 620engaging an annular anchor (not shown). The annular hub 620 may have abuilt-in or coupled annular anchor, such as annular anchor 800 describedherein. The annular anchor may include a helix rotatable with respect tothe annular hub 620. In some embodiments, the coaptation assistanceelement 600 can include a single annular anchor inside the annular hub620. The coaptation assistance element 600 can be deliveredpercutaneously as described herein by attachment of a delivery catheterto the annular hub 620.

As may be seen in FIG. 6, the coaptation assistance element 600 caninclude struts 630. In some embodiments, one, two, or more struts 630have one end terminating at the annular hub 620 and the other endextending radially outwardly toward the superior edge 640, the lateraledges 670 and 675, and the inferior edge 680 of the coaptationassistance element 600. The struts 630 may extend outward from the hub620. The struts 630 may be arranged generally parallel to thelongitudinal axis of the coaptation assistance element 600 to assist inmaintaining the shape of the coaptation assistance element 600 uponplacement. The struts 630 may allow the coaptation assistance element600 to assume a reduced configuration for deployment through a catheter.

The coaptation assistance element 600 can include an annular section610. The annular section 610 can be positioned above the annulus of thenative leaflet when the coaptation assistance element 600 is deployedand form a lip as shown. In some embodiments, the annular section 610may be may be curved upwardly, e.g., away from the annulus and in adirection substantially opposite from, and substantially parallel to thecoaptation surface 660, and form the superior-most portion of thecoaptation assist element 600 when implanted. The annular section 610can be convex. In other embodiments, the annular section 610 may be maybe substantially flat with respect to the annulus. One or more of thestruts 630 may curve laterally from the annular hub 620 toward thesuperior edge 640 to assist in maintaining the shape of the annularsection 610 of the coaptation assistance element 600 upon deployment.The coaptation assistance element 600 can curve upward from the annularhub 620. In some embodiments, the superior edge 640 does not restagainst the posterior leaflet. The superior edge 640 can include anannular radius of curvature. The annular curve radius can curve awayfrom the annulus. The annular curve radius can curve toward thecoaptation surface 660. In some embodiments, the annular curve radiuscan be between 0 mm-5 mm, 5 mm-10 mm, 10 mm-15 mm, 15 mm-20 mm, 20 mm-25mm, 25 mm-30 mm, etc., or ranges incorporating any two of the previousvalues. The coaptation assistance element body covering 650 may besimilar to the coaptation assistance element body covering 550 describedherein.

In some embodiments, the perimeter of the annular section 610 is cuppedupward and in a direction substantially opposite to the longitudinalaxis of the coaptation surface 660. In some embodiments, the coaptationassistance element 600 includes annular anchor site similar to annularanchor site 535. In other embodiments, the coaptation assistance element600 does not include annular anchor site as shown in FIG. 6.

FIGS. 7A-7E illustrate an embodiment of a coaptation assistance element700. The coaptation assistance element 700 can be similar to thecoaptation assistance elements 500 or 600, and can include any featuredescribed herein, with certain elements described below.

The coaptation assistance element 700 can include a first surface 705and a second surface 715. FIG. 7A illustrates a perspective view of thefirst surface 705 or inferior surface disposed toward a mal-coaptingnative leaflet, in the instance of a mitral valve, the posteriorleaflet. FIG. 7B illustrates a perspective view of the second surface715 or superior surface which may be disposed toward the anteriorleaflet. The second surface 715 can include a coaptation surface 760.The superior edge 740 of the coaptation assistance element 700 may becurved to match the general shape of the annulus or adjoining atrialwall. The superior edge 740 can be curved downward, toward the posteriorleaflet, as shown in FIG. 7B. FIG. 7C illustrates a top view of thecoaptation assistance element 700.

FIGS. 7A-7C show a view of the coaptation assistance element 700 with anannular hub 720. The coaptation assistance element 700 can include theannular hub 720 designed to engage the annular anchor 800. The annularanchor 800 may be engaged at a proximal end by a driver, describedherein. The annular hub 720 may have a built-in or coupled annularanchor 800. The annular anchor 800 may comprise a helix rotatable withrespect to the annular hub 720. The coaptation assistance element 700can be delivered percutaneously as described herein by attachment of adelivery catheter to the annular hub 720.

As may be seen in FIGS. 7A-7C, the coaptation assistance element 700 caninclude struts 730. In some embodiments, one or more struts 730 have oneend terminating at the annular hub 720 and the other end extendingradially outwardly toward the superior edge 740, the lateral edges 770and 775, and the inferior edge 780 of the coaptation assistance element700 shown in FIG. 7B. The annular anchor site 735 is shown extendingdownward from the body of the coaptation assistance element 700 in FIG.7B. The annular anchor 800 can be an active anchor. The annular anchorsites 735 can be a passive anchor, such as barbs. The annular anchorsites 735 can be at the distal ends of one or more struts 730.

The annular section 710 can be positioned above the native leaflets whenthe coaptation assistance element 700 is deployed. In some embodiments,the annular section 710 may be may be curved toward the annulus oratrial wall. One or more of the struts 730 may curve laterally from thehub 720 toward the superior edge 740 to assist in maintaining the shapeof the annular section 710 of the coaptation assistance element 700 upondeployment. The coaptation assistance element 700 can curve downwardfrom the annular hub 720 toward the annular anchor site 735. The annularsection 710 can be concave. In some embodiments, one or more supportstructures may be provided which run parallel to the superior edge 740of the coaptation assistance element 700 and assist in maintaining theshape of the superior edge 740. The struts 730 and/or other supportstructures of the frame can be laser-cut from a Nitinol tube in someembodiments. The valve body covering 750 may be comprised of a materialas described herein.

In some embodiments, the coaptation assistance element 700 includes anactive anchor such as annular anchor 800. In some embodiments, thecoaptation assistance element 700 includes a passive anchor such asannular anchor site 735. The annular anchor site 735 can include barbsat the tip of one or more struts 730.

The coaptation assistance element 700, as well as any coaptationassistance element 500, 600 described herein, can include one or moremarkers 900. The marker 900 can be positioned on any portion of thecoaptation assistance element 500, 600, 700 or any element thereof, suchas the struts 530, 630, 730, the annular hub 520, 620, 720, thepurse-string suture 1010, and/or the annular anchor sites 535, 735. Insome embodiments, the marker 900 is positioned on the annular anchor800. In other embodiments, the marker 900 is integrally formed with thecoaptation assistance element 500, 600, 700 or the annular anchor 800. Aplurality of markers 900 can be arranged in specific patterns, on thecoaptation assistance element, to provide a fluoroscopic visual aid forthe operator to accurately orient and position the coaptation assistanceelement 500, 600, 700 and/or the annular anchor 800 within the heart ofa patient.

In some embodiments, the markers 900 may be radio-opaque or they may becovered by a radio graphic marker. During the process of delivery of thecoaptation assistance element 500, 600, 700 and/or the annular anchor800, the markers 900 may be visualized if a fluoroscope is used. Themarker 900 can help position the coaptation assistance element 500, 600,700 and/or the annular anchor 800 within the heart of a patient. In someembodiments, torque can be applied to the annular anchor 800 such thatthe annular anchor 800 is driven into the tissue. To provide feedbackwhether the annular anchor 800 is secured appropriately, fluoroscopicmarkers 900 may be present on the annular anchor 800. The markers may belocated at the proximal end. These markers 900 may inform the medicalteam about how far the annular anchor 800 may have travelled towards theannular hub 520, 620, 720 and may be informative about when the annularanchor 800 is securely in place. In some embodiments, to ensure thatappropriate torque is applied, the torque level at a handle may spike asthe annular anchor 800 bottoms out on the annular hub 520, 620, 720. Thesystems described herein can include one or more markers 900 (e.g., one,two, three, four, five, six, seven, eight, nine, ten, more than one,more than two, more than three, more than four, etc.). The systemsdescribed herein can include two or more different markers 900. Thedifferent markers can indicate different components of the system,different portions of the coaptation assistance element 500, 600, 700 orpositioning points such as the most proximal point, most distal point,midline, etc.

FIGS. 7D-7E illustrate an embodiment of the coaptation assistanceelement 700 deployed within the heart mitral valve model. Referring backto FIG. 1F, the coaptation zone CL between the leaflets is not a simpleline, but rather a curved funnel-shaped surface interface as shown inFIG. 7C. The first 110 (Anterio-lateral or left) and second 114(Posterio-medical or right) commissures are where the anterior leaflet12 meets the posterior leaflet at the coaptation zone, which form thecoaptation line (CL). As seen most clearly in the axial views from theatrium of FIG. 7D, an axial cross-section of the coaptation zonegenerally shows the curved line CL that is separated from a centroid ofthe annulus as well as from the opening through the valve duringdiastole. In addition, the leaflet edges are scalloped, more so for theposterior versus the anterior leaflet. Mal-coaptation can occur betweenone or more of these A-P (anterior-posterior) segment pairs A1/P1,A2/P2, and A3/P3, so that mal-coaptation characteristics may vary alongthe curve of the coaptation zone CL, as shown in FIG. 1F.

In some embodiments, the coaptation assistance element 700 is placedover the posterior leaflet to create a new surface onto which the nativeleaflet, here the anterior leaflet, can coapt. The mitral valve is shownwith the anterior leaflet 12. The zone of coaptation occurs between theanterior leaflet 12 and the coaptation surface 760 of the coaptationassistance element 700.

Referring now to FIG. 8A, aspects of the delivery catheter 1000 areillustrated. The delivery catheter 1000 can include a control handle.The delivery catheter 1000 can include a tip deflection control 1001.The tip deflection control 1001 can allow a distal portion of thedelivery catheter 1000 to deflect. This may be advantageous to place thecoaptation assistance element 500, 600, 700 within the mitral valve. Thedelivery catheter 1000 can be inserted into a transseptal sheath (notshown). The transseptal sheath allows the introduction of the deliverycatheter into the left atrium. The delivery catheter 1000 may furtherinclude one or more ports 1002, such as a flush, irrigation and/oraspiration port to remove the air from the system and allow injection offluids such as saline or contrast media to the site of implantation. Thecatheter 1000 can include a catheter shaft 1006. The catheter 1000 caninclude an implant inserter 1007.

The delivery catheter 1000 may include an implant control knob 1003. Theimplant control knob 1003 can control the movements of the coaptationassistance element 500, 600, 700. The implant control knob 1003 mayenable the collapse of the coaptation assistance element 500, 600, 700.The implant control knob 1003 may enable the expansion of the coaptationassistance element 500, 600, 700. The arrow 1003 a indicates thedirection of movement of the implant control knob 1003 for thecoaptation assistance element 500, 600, 700 to be collapsed by thedelivery catheter 1000 and/or expanded by the delivery catheter 1000.The implant control knob 1003 may enable the rotation of the coaptationassistance element 500, 600, 700. The arrow 1003 b indicates thedirection of movement of the implant control knob 1003 for thecoaptation assistance element 500, 600, 700 to be rotated.

The implant control knob 1003 can be internally connected to thecoaptation assistance element 500, 600, 700 to allow the transmission ofaxial movement and/or torque. For instance, the implant control knob1003 of the delivery catheter 1000 can be coupled to the annular hub520, 620, 720 For instance, the implant control knob 1003 can beconnected to one or more purse-string suture 1010 which may control thedeployment of the coaptation assistance element 500, 600, 700. Thepurse-string suture 1010 may facilitate the collapse and/or expansion ofthe coaptation assistance element 500, 600, 700 as described herein. Thepurse-string suture 1010 may facilitate the rotation of the coaptationassistance element 500, 600, 700 as described herein. In someembodiments, the delivery catheter 1000 releasably engages coaptationassistance element 500, 600, 700 such that axial movement and torque canbe transmitted from the delivery catheter 1000 to the coaptationassistance element 500, 600, 700

In some embodiments, a tip 1300 of the delivery catheter 1000 isreleasably coupled to the annular hub 520, 620, 720 For instance, thetip 1300 of the delivery catheter 1000 can lock onto the annular hub520, 620, 720 such that movement of the delivery catheter 1000 causesmovement of the coaptation assistance element 500, 600, 700. In someembodiments, the system includes a release mechanism between thedelivery catheter 1000 and the annular hub 520, 620, 720.

The annular hub 520, 620, 720 may have features, which can lock with thetip 1300 of the delivery catheter 1000. Referring back to FIGS. 5A-7E,the annular hub 520, 620, 720 can include one or more features to engagea portion of the delivery catheter 1000. The feature can include one ormore notches in the hub 520 of the Implant as shown in FIG. 5A. Thefeature can include an internal lip as shown in FIG. 9A. The feature caninclude windows accessible from the outside of the hub 520, 620, 720, asshown in FIG. 8C. The feature can include any structure or mechanismcapable of coupling the annular hub 520, 620, 720 and a portion of thedelivery catheter 1000. In some embodiments, the annular hub 520, 620,720 and the delivery catheter 1000 are coupled via a screw mechanism.For instance, the annular hub 520, 620, 720 can include a female threadand the distal end of the delivery catheter 1000 can include a malethread. In some embodiments, the annular hub 520, 620, 720 and thedelivery catheter 1000 are coupled via a noose and pin configuration.For instance, the annular hub 520, 620, 720 can include a pin such as anoutwardly extending pin and the distal end of the delivery catheter 1000can include a loop or noose designed to be tightened around the pin.Other configurations are contemplated.

FIG. 8B shows the coaptation assistance element 500, 600, 700 coupled tothe delivery catheter 1000. The coaptation assistance element 500, 600,700 can be collapsed as shown or expanded as shown by the dashed linesby movement along arrow 1003 a. The coaptation assistance element 500,600, 700 can be rotated as shown by the dashed lines by movement alongarrow 1003 b.

Referring to FIG. 8C, the delivery catheter 1000 can include the tip1300. The distal end of the tip 1300 can include distal locking tabs. Insome embodiments, the tip 1300 includes a plurality of pre-bent orshape-set locking tabs. In some embodiments, the tip includes twolocking tabs, three locking tabs, four locking tabs, five locking tabs,a plurality of locking tabs, a multitude of locking tabs, etc. This“AT-lock” (axial-torsional lock) can include nitinol locking tabs on thetip 1300. In some embodiments, the locking tabs of the tip 1300 can beactuated by a sheath 1350. In some embodiments, the sheath 1350 ishollow to allow movement of other components such as the driverdescribed herein. The movement sheath 1350 can force the locking tabsinward into engagement with the annular hub 520, 620, 720. In someembodiments, the locking tabs of the tip 1300 engage a feature such as awindow or lip of the annular hub 520, 620, 720. In some embodiments,movement of the sheath 1350 in the opposite direction can cause therelease of the annular hub 520, 620, 720 from the tip. In otherembodiments, the locking tabs of the tip 1300 can be actuated by acentral pin inserted within tip 1300 (not shown). In some embodiments,the central pin is hollow to allow movement of other components such asthe driver described herein. The movement of the central pin can forcethe locking tabs outward into engagement with the annular hub 520, 620,720.

In some embodiments, the distal end of the tip 1300 can be actuated tolock the delivery catheter 1000 to the annular hub 520, 620, 720. Insome embodiments, the distal end of the tip 1300 can be actuated tounlock the delivery catheter 1000 from the annular hub 520, 620, 720. Asdescribed herein, secondary structures such as the purse-string suturesmay remain coupled to the coaptation assistance element 500, 600, 700after the annular hub 520, 620, 720 is released from the tip 1300. Insome embodiments, when the delivery catheter 1000 is unlocked, one ormore secondary structures such as the purse-string sutures describedherein can retain a relative position between the delivery catheter 1000and the annular hub 520, 620, 720. During a procedure, the tip 1300 maybe repeatedly locked and unlocked.

Referring back to FIG. 8A, the delivery catheter 1000 can include theanchor control knob 1004. In some embodiments, the anchor control knob1004 can enable the release of the annular anchor 800 and/or thecoaptation assistance element 500, 600, 700. In some embodiments, theanchor control knob 1004 can enable the engagement of the annular anchor800 for instance to rotate the annular anchor 800 and/or to axially movethe annular anchor 800. In some embodiments, the anchor control knob1004 can enable the disengagement of the annular anchor 800. In someembodiments, the anchor control knob 1004 can control a driver 1200configured to apply torque. In some embodiments, the anchor control knob1004 can control a driver 1200 configured to apply tension and/orrelease the coaptation assistance element 500, 600, 700. In someembodiments, the anchor control knob 1004 can control a driver 1200configured to apply tension and torque.

The anchor control knob 1004 of the delivery catheter 1000 may becoupled to the annular anchor 800 to allow transmission of torque to theannular anchor 800. The anchor control knob 1004 may enable simplemanipulation of the torque or position of the annular anchor 800. Thearrow 1004 a indicates the direction of movement of the anchor controlknob 1004 for the annular anchor 800 to be engaged or disengaged. Forinstance, moving the anchor control knob 1004 toward the annular anchor800 may engage a driver 1200 with the annular anchor 800. The arrow 1004b indicates the direction of movement of the anchor control knob 1004for the transmission of torque to the annular anchor 800. In someembodiments, the arrow 1004 b indicates the direction to release theannular anchor 800. For instance, the further application of torque maytwist the driver 1200 out of engagement with the annular anchor 800.

An embodiment of an annular anchor 800 is illustrated in detail in FIG.9A. Other components of the delivery catheter 1000 are not shown in FIG.9A, such as the component which engages the annular hub 520, 620, 720.The annular anchor 800 may be coupled to the driver 1200 in variousways, as described herein. The annular anchor 800 may be coupled to thecoaptation assistance element 500, 600, 700 in various ways. In someembodiments, the annular hub 520, 620, 720 may have a cross-pin 820. Thecross-pin 820 can provide a site about which a helical structure 815 ofthe annular anchor 800 may wrap around as shown. The annular anchor 800can have a shoulder 805. The shoulder 805 may fit around the outside ofa driver 1200 of the delivery catheter 1000.

In some embodiments, the driver 1200 is releasably coupled to theannular anchor 800. The driver 1200 can be coupled and/or controlled bythe anchor control knob 1004 described herein. One or more drivers 1200can deliver torque to drive the annular anchor 800 into tissue. One ormore drivers 1200 can deliver tension to hold and/or release the annularanchor 800. In some embodiments, a single driver 1200 delivers torqueand tension. In other embodiments, two or more drivers 1200 delivertorque and tension. For instance, the driver 1200 can lock onto theannular anchor 800 such that movement of the driver 1200 causes movementof the annular anchor 800. In some embodiments, the system includes arelease mechanism between the driver 1200 and the annular anchor 800. Insome embodiments, the distal end of the driver 1200 can be actuated tolock the driver 1200 to the annular anchor 800. In some embodiments, thedistal end of the driver 1200 can be actuated to unlock the driver 1200from the annular anchor 800. In some embodiments, when the driver 1200is unlocked, one or more secondary structures such as the purse-stringsutures can retain a relative position between the delivery catheter1000 and the annular anchor 800. During a procedure, the driver 1200 maybe repeatedly locked and unlocked.

FIG. 9B illustrates an embodiment of a driver 1200. The driver 1200 caninclude a torque shaft 1205. The torque shaft 1205 can include a loop1210. The loop 1210 can engage a pin 1215 extending and looping aroundthe tension cross-pin 1270 and through the anchor 800. The rotation ofthe torque shaft 1205 can cause a torque to be applied to a torquecross-pin 1275, thereby causing rotation of the annular anchor 800. Insome embodiments, the annular anchor 800 can include a torque cross-pinand a tension cross-pin. Another driver (not shown) can apply a torqueto the tension cross-pin to apply tension to the annular anchor 800. Oneor more drivers 1200 can engage the annular anchor 800 to delivertorque. One or more drivers 1200 can engage the annular anchor 800 todeliver tension. In some embodiments, delivery of the annular anchor 800is independent of rotation of the coaptation assistance element 500,600, 700.

FIG. 9C illustrates an embodiment of a driver 1200. The driver 1200 caninclude a torque shaft 1220. The torque shaft 1220 can include an anchordocking cap 1225. The anchor docking cap 1225 can engage the annularanchor 800 in a single orientation or one of a plurality oforientations. In some embodiments, the annular anchor 800 includes aprotrusion 1230 and the anchor docking cap 1225 is designed to acceptthe protrusion 1230. In other embodiments, the annular anchor 800includes a recess (not shown) to accept a mating protrusion on theanchor docking cap 1225 (not shown). The rotation of the torque shaft1220 can cause a torque to be applied to the annular anchor 800. Anotherdriver 1235 can apply tension to the annular anchor 800. In someembodiments, the driver 1235 can include a release screw. In otherembodiments, the loop and pin release mechanism described in FIG. 9B maybe used. The release screw can be rotated to release the annular anchor800. One or more drivers 1200 can engage the annular anchor 800 todeliver torque. One or more drivers 1200 can engage the annular anchor800 to deliver tension.

FIG. 9D illustrates an embodiment of a driver 1200 and the annularanchor 800. The driver 1200 can include a torque shaft 1220. The torqueshaft 1220 can include an anchor docking cap 1225. In some embodiments,the annular anchor 800 includes a protrusion 1230 and the anchor dockingcap 1225 is designed to accept the protrusion 1230. In otherembodiments, the annular anchor 800 includes a recess (not shown) toaccept a mating protrusion on the anchor docking cap 1225 (not shown).Two or more wires 1240, 1245 can apply tension to the annular anchor800. In some embodiments, the wire 1240 acts as a pin, and the wire 1245terminates in a ball. In a retained state, the wires 1240, 1245 are bothpositioned within an opening in the annular anchor 800. The opening istoo small to allow the pin and ball end of wires 1240, 1245 to pass sideby side. In some methods of use, the wire 1240 is retracted first. Theretraction of the wire 1240 yields sufficient room to allow retractionof the wire 1245. The wires 1240, 1245 can be actuated to release theannular anchor 800. One or more drivers 1200 can engage the annularanchor 800 to deliver torque. One or more drivers 1200 can engage theannular anchor 800 to deliver tension

FIG. 9E illustrates an embodiment of the driver 1200. The driver 1200can include a torque shaft 1255. The shoulder 805 may have features suchas windows 810 which can lock with one or more distal locking tabs 1265of the torque shaft 1255. The distal locking tabs 1265 may includenitinol material such as a Shape-set NiTi clip. The distal locking tabs1265 may be pushed outward into the windows 810 by a driver 1260. Thedriver 1260 acts as a release mechanism. The longitudinal movement ofthe driver 1260 toward the annular anchor 800 may push the distallocking tabs 1265 outward toward the windows 810. The longitudinalmovement of the driver 1260 away from the annular anchor 800 may allowthe distal locking tabs 1265 to regain a neutral configuration anddisengage from the windows 810. The distal locking tabs 1265 engagedwith the windows 810 of the annular anchor 800 can allow thetransmission of axial movement between the torque shaft 1255 and theannular anchor 800. The distal locking tabs 1265 engaged with thewindows 810 of the annular anchor 800 can allow the transmission oftorque between the torque shaft 1255 and the annular anchor 800. Inembodiments where the annular anchor 800 is built-in or captured by theannular hub 520, 620, 720, the distal locking tabs 1265 engaged with thewindows 810 can allow the transmission of axial movement between thedelivery catheter and the coaptation assistance element 500, 600, 700.

In some embodiments, an advantage is the annular anchor 800 can berotated independently of the coaptation assistance element 500, 600,700. As described herein, the coaptation assistance element 500, 600,700 is coupled to the delivery catheter 1000. As described herein, theannular anchor 800 is independently coupled to the driver 1200. Theannular anchor 800 can be rotated independently of the annular hub 520,620, 720. The annular hub 520, 620, 720 can remain stationary as theannular anchor 800 is rotated to engage tissue.

In some methods, the annular anchor 800 can be preloaded onto thecoaptation assistance element 500, 600, 700 and coupled to the driver1200 during the process of mounting the coaptation assistance element500, 600, 700 onto the delivery catheter 1000. This can occur before thecoaptation assistance element 500, 600, 700 is pulled into an implantsheath and/or another portion of the delivery catheter 1000 and is beingreadied for insertion into the femoral vein. As disclosed herein, torquecan be applied such that the annular anchor 800 is driven into thetissue. In some embodiments, to ensure that appropriate torque isapplied, the torque level at the handle may spike as the annular anchor800 bottoms out on the annular hub 520, 620, 720. This increased torquelevel may be felt at the handle providing feedback that appropriatetorque has been applied. In other embodiments, radiopaque markings mayaid in visually determining the level of anchor engagement withintissue. In some embodiments, the markings can be located on the annularanchor 800 and/or the coaptation assistance element 500, 600, 700.

FIGS. 10-15 show various method steps, which may be performed during amethod of use of the coaptation assistance element 500, 600, 700. Themethod may include the step of collapsing the coaptation assistanceelement 500, 600, 700. The method may include the step of coupling thecoaptation assistance element 500, 600, 700 to the delivery catheter1000. The method may include the step of coupling the locking tabs 1265with the annular anchor 800 and/or the coaptation assistance element500, 600, 700. The method step can include any step disclosed herein formanufacturing the coaptation assistance element 500, 600, 700.

In some embodiments, an advantage is the coaptation assistance element500, 600, 700 can be delivered with a hub-leading orientation. In thismethod of use, the annular hub 520, 620, 720 can be moved into positionrelative to the anatomical structures prior to another portion of thecoaptation assistance element 500, 600, 700. In some methods of use, theventricular end of the coaptation assistance element 500, 600, 700 canbe retained within the delivery catheter 1000 until the annular hub 520,620, 720 is positioned. In some methods of use, once the annular hub520,620, 720 and/or the annular anchor 800 are engaged with the tissue,the coaptation assistance element 500, 600, 700 can be expanded. In somemethods of use, once the annular hub 520, 620, 720 and/or the annularanchor 800 are engaged with the tissue, the ventricular end of thecoaptation assistance element 500, 600, 700 can be positioned.

In some embodiments, an advantage is the coaptation assistance element500, 600, 700 can be delivered with a strut-leading orientation. In thismethod of use, one or more of the struts 530, 630, 730 of the coaptationassistance element 500, 600, 700 can be moved into position relative tothe anatomical structures prior to another portion of the coaptationassistance element 500, 600, 700. In some methods of use, the coaptationassistance element 500, 600, 700 can be expanded or partially expandedprior to the positioning of the annular hub 520, 620, 720. In somemethods of use, the annular hub 520, 620, 720 can be retained within thedelivery catheter until one or more of the struts 530, 630, 730 arepositioned. In some methods of use, once the struts 530, 630, 730 arepositioned, the annular anchor 800 is engaged with the tissue.

FIG. 10 illustrates an embodiment of transsseptal crossing. The methodstep may include femoral vein access. Access may be gained through avessel such as the femoral vein in order to reach a chamber of the heartsuch as the right atrium 1300. The left ventricle 1380 and its papillarymuscles are also shown 1360. The method may include the step oftransseptal puncture and crossing with standard transseptal kit 1330 tothe left atrium 1320. The method may include the step of exchanging forcustom transseptal sheath and delivery catheter 1000, as describedherein. A transseptal puncture kit may be exchanged for a transseptalsheath and dilator, and the dilator may be exchanged for an implantdelivery catheter which may be as disclosed herein and in U.S. Pat. No.8,888,843 to Khairkhahan et al., incorporated by reference in itsentirety. The method may include the step of removing a dilator. Themethod may include the step of advancing the delivery catheter 1000.However, other approaches such as transapical, transatrial, femoralartery, brachial artery, and the like are also within the scope of theinvention.

FIG. 11 illustrates initial advancement of the coaptation assistanceelement 500, 600, 700. The method may include the step of advancing thecoaptation assistance element 500, 600, 700 inside the retrieval sheath.The retrieval sheath can include a tip having a plurality of petalsradiating from a central hub 1420. The retrieval sheath may bepositioned within a transseptal sheath 1400. The mitral valve is show atthe base of the left atrium 1440. The method may include the step ofadvancing the annular section 510, 610, 710 toward the annulus beforeadvancing the coaptation surface 560, 660, 760 toward the annulus. Themethod may include the step of deploying the ventricular end or inferiorsurface 580 after deploying the annular portion 510.

FIG. 12 illustrates partial deployment of the coaptation assistanceelement 500, 600, 700. The coaptation assistance element 500, 600, 700may be advanced in proximity to the target location under imagingguidance such as ultrasound or fluoroscopy. The annular anchor 800coupled with the coaptation assistance element 500, 600, 700 is engagedin tissue. An anchor torque shaft 1540 may be rotated internally andindependent of the rotation of an implant torque shaft (not shown).Controlled release of a purse-string suture 1010 around the perimeter ofthe coaptation assistance element 500, 600, 700 may cause the coaptationassistance element 500, 600, 700 to expand. Prior to full expansion ofthe coaptation assistance element 500, 600, 700, rotational adjustmentof the coaptation assistance element 500, 600, 700 may be performed toalign the interior (ventricular) section of the coaptation assistanceelement 500, 600, 700 with a valve opening 1580.

The method may include the step of advancing the coaptation assistanceelement 500, 600, 700 toward a target location. The method may includethe step of advancing the annular hub 520, 620, 720 toward a targetlocation. The method may include the step of advancing the annularanchor 800, which is coupled to the annular hub 520, 620, 720, toward atarget location. The method may include echo or fluoroscopic guidance ofthe annular anchor 800, the hub 520, 620, 720, and/or the coaptationassistance element 500, 600, 700. The method may include engaging theannular anchor 800 in tissue. The method may include rotating the anchorcontrol knob 1004 to rotate the annular anchor 800. The method mayinclude the independent rotation of the annular anchor 800 from the hub520, 620, 720. The method may include holding the hub 520, 620, 720stationary during rotation of the annular anchor 800. The method mayinclude controlled release of the purse-string suture 1010. The releasemay cause the coaptation assistance element 500, 600, 700 to expand. Thepurse-string suture 1010 may be disposed within the coaptationassistance element 500, 600, 700 and/or along a perimeter of thecoaptation assistance element 500, 600, 700. The purse-string suture1010 can facilitate the collapse and/or expansion of the coaptationassistance element 500, 600, 700. The method may include rotationaladjustment of the coaptation assistance element 500, 600, 700 to alignan inferior edge 580, 680, 780 or ventricular section of the coaptationassistance element 500, 600, 700 with the valve opening. The method mayinclude rotational adjustment of the coaptation assistance element 500,600, 700 to align an inferior edge 580, 680, 780 or ventricular sectionaround the posterior leaflet.

FIG. 13 illustrates recapture of the coaptation assistance element 500,600, 700. The coaptation assistance element 500, 600, 700 may berecaptured by tightening a purse-string suture 1010 around a portion ofthe perimeter 1620 of the coaptation assistance element 500, 600, 700 tocollapse the coaptation assistance element 500, 600, 700. The perimetercan include any edge, any combination of edges, or all of the edgesdescribed herein. A recapture sheath and transseptal sheath 1600 may beadvanced over the collapsed coaptation assistance element 500, 600, 700.Recapture sheath petals that radiate from a central hub may roll overthe coaptation assistance element 500, 600, 700 allowing the coaptationassistance element 500, 600, 700 to be retracted into the transseptalsheath. The annular anchor 800 may be unscrewed or otherwise released,and the system may be removed. The prolapsed or partially encapsulatedcoaptation assistance element 500, 600, 700 by the recapture sheathpetals can be another mode of delivery. The encapsulated-first deliverymode can be in contrast to the hub-first and the strut-delivery modesdescribed herein.

In some methods, recapture is an optional method step. The method mayinclude the step of tightening of the purse-string suture 1010. Thistightening may collapse the coaptation assistance element 500, 600, 700.The method may include the step of advancing the recapture sheath and/orthe transseptal sheath over the collapsed coaptation assistance element500, 600, 700. The recapture sheath can fold outward to roll over thecoaptation assistance element 500, 600, 700. The method may include thestep of retracting the coaptation assistance element 500, 600, 700 intothe transseptal sheath. The method may include the step of rotating theannular anchor 800 to disengage tissue. The method may include the stepof removing the coaptation assistance element 500, 600, 700 and theannular anchor 800.

FIG. 14 illustrates a cross-section view of the deployed coaptationassistance element 500, 600, 700. The method may include the step ofreleasing of the coaptation assistance element 500, 600, 700. The methodmay include the step of retraction of the delivery catheter 1000.

FIG. 15 illustrates deployment of secondary anchors. In some methods,deployment of secondary anchors is an optional method step. The methodmay include the step of engaging annular attachment sites 535, 735 tothe annulus. The method may include the step of engaging ventricularanchors. The method may include the step of engaging commissural anchors1800. The method may include the step of deploying markers on strategiclocations on the coaptation assistance element 500, 600, 700 and/or theannular anchor 800. The method may include the step of detectingmarkers, such as detecting radiopaque markers. The method may includethe step of facilitating the placement of anchor 800 under fluoroscopy.The method may include the step of locating radiopaque markers along theperimeter of the coaptation assistance element 500, 600, 700 to indicatethe shape of coaptation assistance element 500, 600, 700.

In some embodiments, the manufacturer provides instructions for use ofthe system including one or more of the steps disclose herein, or anystep previously described or inherent in the drawings.

It is contemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment can be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the invention issusceptible to various modifications, and alternative forms, specificexamples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “inserting a coaptation assist body proximate the mitralvalve” includes “instructing the inserting of a coaptation assist bodyproximate the mitral valve.” The ranges disclosed herein also encompassany and all overlap, sub-ranges, and combinations thereof. Language suchas “up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“approximately”, “about”, and “substantially” as used herein include therecited numbers, and also represent an amount close to the stated amountthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately”, “about”, and “substantially” mayrefer to an amount that is within less than 10% of, within less than 5%of, within less than 1% of, within less than 0.1% of, and within lessthan 0.01% of the stated amount.

What is claimed is:
 1. A coaptation assistance element for treatingmal-coaptation of a heart valve of a heart, the coaptation assistanceelement comprising: a first coaptation surface and an opposed secondsurface; a first lateral edge, a second lateral edge, an inferior edge,and a superior edge; a hub spaced inward from each of the first lateraledge, the second lateral edge, the inferior edge, and the superior edge;and an active anchor configured to couple to the hub and configured tobe rotated relative to the hub to selectively deploy the active anchorat a first target location; and a plurality of struts spaced around thehub and extending outward from the hub, the plurality of strutscomprising at least a first strut configured to be implanted within theheart and a second strut configured to be implanted within the heartsuch that the first coaptation surface coapts with a first leaflet ofthe heart valve and the opposed second surface overlays a second leafletof the heart valve.
 2. The coaptation assistance element of claim 1,wherein the second strut has a total length that is longer than a totallength of the first strut.
 3. The coaptation assistance element of claim1, wherein the hub is an annular hub.
 4. The coaptation assistanceelement of claim 1, further comprising a covering overlying a portion ofthe plurality of struts.
 5. The coaptation assistance element of claim4, wherein at least one strut of the plurality of struts has a sharpenedtip extending from the covering.
 6. The coaptation assistance element ofclaim 1, further comprising a suture, wherein the suture is configuredcollapse the coaptation assistance element.
 7. The coaptation assistanceelement of claim 1, wherein the plurality of struts comprise Nitinol. 8.The coaptation assistance element of claim 1, further comprising one ormore additional anchors.
 9. The coaptation assistance element of claim1, further comprising a radiopaque marker.
 10. The coaptation assistanceelement of claim 1, wherein the hub is configured to extend upward froman annulus of the heart valve.
 11. The coaptation assistance element ofclaim 1, wherein the hub and the plurality of struts are formed from atube.
 12. The coaptation assistance element of claim 1, wherein theplurality of struts and the hub are integrally formed.
 13. A coaptationassistance element for treating mal-coaptation of a heart valve of aheart, the coaptation assistance element comprising: a first coaptationsurface and an opposed second surface; a first lateral edge, a secondlateral edge, an inferior edge, and a superior edge; a hub; an anchorconfigured to be coupled to the hub, the anchor configured to be rotatedin a first direction relative to the hub to engage a tissue at a firsttarget location, the anchor configured to be rotated in a seconddirection, opposite the first direction, relative to the hub toselectively disengage the tissue at the first target location; and aplurality of struts extending outward from the hub, the plurality ofstruts comprising at least a first strut configured to be implantedwithin the heart superior to the heart valve and a second strutconfigured to be implanted within the heart and traversing the heartvalve.
 14. The coaptation assistance element of claim 13, wherein twostruts of the plurality of struts have different lengths.
 15. Thecoaptation assistance element of claim 13, wherein at least one strut ofthe plurality of struts is bifurcated.
 16. The coaptation assistanceelement of claim 13, wherein at least one strut of the plurality ofstruts comprise an eyelet.
 17. The coaptation assistance element ofclaim 13, wherein at least one strut of the plurality of struts comprisea barb configured to be secured to a leaflet.
 18. The coaptationassistance element of claim 13, wherein at least one strut of theplurality of struts comprise a portion configured to increaseflexibility of the strut.
 19. The coaptation assistance element of claim13, further comprising a covering coupled to the plurality of struts.20. A coaptation assistance element for treating mal-coaptation of aheart valve of a heart, the heart valve having an annulus, thecoaptation assistance element comprising: a first coaptation surface andan opposed second surface; a first lateral edge, a second lateral edge,an inferior edge, and a superior edge; a hub; an annular anchorconfigured to be coupled to the hub and configured to be rotatedrelative to the hub to selectively deploy the annular anchor at a firsttarget location, wherein the hub is configured to remain stationary asthe annular anchor is rotated to engage tissue; and a plurality ofstruts spaced around the hub and extending outward from the hub, theplurality of struts comprising at least a first strut configured to beimplanted within the heart and a second strut configured to be implantedwithin the heart to position the annular anchor near the annulus.